The Experts below are selected from a list of 327 Experts worldwide ranked by ideXlab platform

Colin Powell - One of the best experts on this subject based on the ideXlab platform.

  • treating Acute Severe Asthma attacks in children using aminophylline
    Breathe, 2020
    Co-Authors: Colin Powell, A Aralihond, Z Shanta, A Pullattayil
    Abstract:

    Aminophylline does have a role in treating Severe Asthma attacks in children with Asthma. Clinicians just need to be aware of the toxic side-effects of the drug and manage the drug carefully. https://bit.ly/3o7IJV1.

  • Acute Severe paediatric Asthma study protocol for the development of a core outcome set a pediatric emergency reserarch networks pern study
    Trials, 2020
    Co-Authors: Colin Powell, Simon Craig, Franz E Babl, Stuart R Dalziel, Charmaine S Gray, Khalid Al Ansari
    Abstract:

    Acute Severe childhood Asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. A 5-stage approach will be used: (1) a comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) we will review current clinical practice guidelines, existing clinical trials, and literature on bedside assessment of Asthma severity. We will then identify practice differences in tne clinical assessment of Asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials in Acute paediatric Asthma in the emergency department (ED) setting; (4) a retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications such as intubation, ICU admission, and death in children hospitalized with Acute Severe Asthma. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in Asthma in the ED setting; and finally (5) a meeting of the Pediatric Emergency Research Networks (PERN) Asthma working group will be held, with invitation of other clinicians interested in Acute Asthma research, and patients/families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials in Acute Severe Asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for randomized controlled trials (RCTs) in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition.

  • Acute Severe paediatric Asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Reserarch Networks (PERN) study.
    2020
    Co-Authors: Simon Craig, Colin Powell, Franz E Babl, Stuart R Dalziel, Charmaine Gray, Khalid Al Ansari, Mark D Lyttle, Damian Roland, Javier Benito, Roberto Velasco
    Abstract:

    BACKGROUND:Acute Severe childhood Asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom. METHODS/DESIGN:A 5-stage approach will be used: (1) a comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) we will review current clinical practice guidelines, existing clinical trials, and literature on bedside assessment of Asthma severity. We will then identify practice differences in tne clinical assessment of Asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials in Acute paediatric Asthma in the emergency department (ED) setting; (4) a retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications such as intubation, ICU admission, and death in children hospitalized with Acute Severe Asthma. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in Asthma in the ED setting; and finally (5) a meeting of the Pediatric Emergency Research Networks (PERN) Asthma working group will be held, with invitation of other clinicians interested in Acute Asthma research, and patients/families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials in Acute Severe Asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim. DISCUSSION:The development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for randomized controlled trials (RCTs) in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition

  • economic evaluation of nebulized magnesium sulphate in Acute Severe Asthma in children
    International Journal of Technology Assessment in Health Care, 2014
    Co-Authors: Stavros Petrou, Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Iolo Doull, Kerenza Hood, Kamran Khan, Paula R Williamson
    Abstract:

    Objectives: The aim of this study was to estimate the cost-effectiveness of nebulized magnesium sulphate (MgSO4) in Acute Asthma in children from the perspective of the UK National Health Service and personal social services. Methods: An economic evaluation was conducted based on evidence from a randomized placebo controlled multi-center trial of nebulized MgSO4 in Severe Acute Asthma in children. Participants comprised 508 children aged 2–16 years presenting to an emergency department or a children's assessment unit with Severe Acute Asthma across thirty hospitals in the United Kingdom. Children were randomly allocated to receive nebulized salbutamol and ipratropium bromide mixed with either 2.5 ml of isotonic MgSO4 or 2.5 ml of isotonic saline on three occasions at 20-min intervals. Cost-effectiveness outcomes were constructed around the Yung Asthma Severity Score (ASS) after 60 min of treatment; whilst cost-utility outcomes were constructed around the quality-adjusted life-year (QALY) metric. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative cost-effectiveness thresholds for either: (i) a unit reduction in ASS; or (ii) an additional QALY. Results: MgSO4 had a 75.1 percent probability of being cost-effective at a GBP 1,000 (EUR 1,148) per unit decrement in ASS threshold, an 88.0 percent probability of being more effective (in terms of reducing the ASS) and a 36.6 percent probability of being less costly. MgSO4 also had a 67.6 percent probability of being cost-effective at a GBP 20,000 (EUR 22,957) per QALY gained threshold, an 8.5 percent probability of being more effective (in terms of generating increased QALYs) and a 69.1 percent probability of being less costly. Sensitivity analyses showed that the results of the economic evaluation were particularly sensitive to the methods used for QALY estimation. Conclusions: The probability of cost-effectiveness of nebulized isotonic MgSO4, given as an adjuvant to standard treatment of Severe Acute Asthma in children, is less than 70 percent across accepted cost-effectiveness thresholds for an additional QALY.

  • magnesium trial in children magnetic a randomised placebo controlled trial and economic evaluation of nebulised magnesium sulphate in Acute Severe Asthma in children
    Health Technology Assessment, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, Stavros Petrou, Iolo Doull, Kerenza Hood, Alison Boland, Paula R Williamson
    Abstract:

    Background: There are few data on the role of nebulised magnesium sulphate (MgSO4) in the management of Acute Asthma in children. Those studies that have been published are underpowered, and use different methods, interventions and comparisons. Thus, no firm conclusions can be drawn. Objectives: Does the use of nebulised MgSO4, when given as an adjunct to standard therapy in Acute Severe Asthma in children, result in a clinical improvement when compared with standard treatment alone? Design: Patients were randomised to receive three doses of MgSO4 or placebo, each combined with salbutamol and ipratropium bromide, for 1 hour. The Yung Asthma Severity Score (ASS) was measured at baseline, randomisation, and at 20, 40, 60 (T60), 120, 180 and 240 minutes after randomisation. Setting: Emergency departments and children's assessment units at 30 hospitals in the UK. Participants: Children aged 2-15 years with Acute Severe Asthma. Interventions: Patients were randomised to receive nebulised salbutamol 2.5 mg (ages 2-5 years) or 5 mg (ages ≥ 6 years) and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic MgSO4 (250 mmol/l, tonicity 289 mOsm; 151 mg per dose) or 2.5 ml of isotonic saline on three occasions at approximately 20-minute intervals. Main outcome measures: The primary outcome measure was the ASS after 1 hour of treatment. Secondary measures included 'stepping down' of treatment at 1 hour, number and frequency of additional salbutamol administrations, length of stay in hospital, requirement for intravenous bronchodilator treatment, and intubation and/or admission to a paediatric intensive care unit. Data on paediatric quality of life, time off school/nursery, health-care resource usage and time off work were collected 1 month after randomisation. Results: A total of 508 children were recruited into the study; 252 received MgSO4 and 256 received placebo along with the standard treatment. There were no differences in baseline characteristics. There was a small, but statistically significant difference in ASS at T60 in those children who received nebulised MgSO4 {0.25 [95% confidence interval (CI) 0.02 to 0.48]; p = 0.034} and this difference was sustained for up to 240 minutes [0.20 (95% CI 0.01 to 0.40), p = 0.042]. The clinical significance of this gain is uncertain. Assessing treatment-covariate interactions, there is evidence of a larger effect in those children with more Severe Asthma exacerbations ( p = 0.034) and those with a shorter duration of symptoms ( p = 0.049). There were no significant differences in the secondary outcomes measured. Adverse events (AEs) were reported in 19% of children in the magnesium group and 20% in the placebo group. There were no clinically significant serious AEs in either group. The results of the base-case economic analyses are accompanied by considerable uncertainty, but suggest that, from an NHS and Personal Social Services perspective, the addition of magnesium to standard treatment may be cost-effective compared with standard treatment only. The results of economic evaluation show that the probability of magnesium being cost-effective is over 60% at cost-effectiveness thresholds of £1000 per unit decrement in ASS and £20,000 per quality-adjusted life-year (QALY) gained, respectively; it is noted that for some parameter variations this probability is much lower, reflecting the labile nature of the cost-effectiveness ratio in light of the small differences in benefits and costs shown in the trial and the relation between the main outcome measure (ASS) and preference based measures of quality of life used in cost-utility analysis (European Quality of Life-5 Dimensions; EQ-5D). Conclusions: This study supports the use of nebulised isotonic MgSO4 at the dose of 151 mg given three times in the first hour of treatment as an adjuvant to standard treatment when a child presents with an Acute episode of Severe Asthma. No harm is done by adding magnesium to salbutamol and ipratropium bromide, and in some individuals it may be clinically helpful. The response is likely to be more marked in those children with more Severe attacks and with a shorter duration of exacerbation. Although the study was not powered to demonstrate this fully, the data certainly support the hypotheses that nebulised magnesium has a greater clinical effect in children who have more Severe exacerbation with shorter duration of symptoms.

Paula R Williamson - One of the best experts on this subject based on the ideXlab platform.

  • economic evaluation of nebulized magnesium sulphate in Acute Severe Asthma in children
    International Journal of Technology Assessment in Health Care, 2014
    Co-Authors: Stavros Petrou, Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Iolo Doull, Kerenza Hood, Kamran Khan, Paula R Williamson
    Abstract:

    Objectives: The aim of this study was to estimate the cost-effectiveness of nebulized magnesium sulphate (MgSO4) in Acute Asthma in children from the perspective of the UK National Health Service and personal social services. Methods: An economic evaluation was conducted based on evidence from a randomized placebo controlled multi-center trial of nebulized MgSO4 in Severe Acute Asthma in children. Participants comprised 508 children aged 2–16 years presenting to an emergency department or a children's assessment unit with Severe Acute Asthma across thirty hospitals in the United Kingdom. Children were randomly allocated to receive nebulized salbutamol and ipratropium bromide mixed with either 2.5 ml of isotonic MgSO4 or 2.5 ml of isotonic saline on three occasions at 20-min intervals. Cost-effectiveness outcomes were constructed around the Yung Asthma Severity Score (ASS) after 60 min of treatment; whilst cost-utility outcomes were constructed around the quality-adjusted life-year (QALY) metric. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative cost-effectiveness thresholds for either: (i) a unit reduction in ASS; or (ii) an additional QALY. Results: MgSO4 had a 75.1 percent probability of being cost-effective at a GBP 1,000 (EUR 1,148) per unit decrement in ASS threshold, an 88.0 percent probability of being more effective (in terms of reducing the ASS) and a 36.6 percent probability of being less costly. MgSO4 also had a 67.6 percent probability of being cost-effective at a GBP 20,000 (EUR 22,957) per QALY gained threshold, an 8.5 percent probability of being more effective (in terms of generating increased QALYs) and a 69.1 percent probability of being less costly. Sensitivity analyses showed that the results of the economic evaluation were particularly sensitive to the methods used for QALY estimation. Conclusions: The probability of cost-effectiveness of nebulized isotonic MgSO4, given as an adjuvant to standard treatment of Severe Acute Asthma in children, is less than 70 percent across accepted cost-effectiveness thresholds for an additional QALY.

  • magnesium trial in children magnetic a randomised placebo controlled trial and economic evaluation of nebulised magnesium sulphate in Acute Severe Asthma in children
    Health Technology Assessment, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, Stavros Petrou, Iolo Doull, Kerenza Hood, Alison Boland, Paula R Williamson
    Abstract:

    Background: There are few data on the role of nebulised magnesium sulphate (MgSO4) in the management of Acute Asthma in children. Those studies that have been published are underpowered, and use different methods, interventions and comparisons. Thus, no firm conclusions can be drawn. Objectives: Does the use of nebulised MgSO4, when given as an adjunct to standard therapy in Acute Severe Asthma in children, result in a clinical improvement when compared with standard treatment alone? Design: Patients were randomised to receive three doses of MgSO4 or placebo, each combined with salbutamol and ipratropium bromide, for 1 hour. The Yung Asthma Severity Score (ASS) was measured at baseline, randomisation, and at 20, 40, 60 (T60), 120, 180 and 240 minutes after randomisation. Setting: Emergency departments and children's assessment units at 30 hospitals in the UK. Participants: Children aged 2-15 years with Acute Severe Asthma. Interventions: Patients were randomised to receive nebulised salbutamol 2.5 mg (ages 2-5 years) or 5 mg (ages ≥ 6 years) and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic MgSO4 (250 mmol/l, tonicity 289 mOsm; 151 mg per dose) or 2.5 ml of isotonic saline on three occasions at approximately 20-minute intervals. Main outcome measures: The primary outcome measure was the ASS after 1 hour of treatment. Secondary measures included 'stepping down' of treatment at 1 hour, number and frequency of additional salbutamol administrations, length of stay in hospital, requirement for intravenous bronchodilator treatment, and intubation and/or admission to a paediatric intensive care unit. Data on paediatric quality of life, time off school/nursery, health-care resource usage and time off work were collected 1 month after randomisation. Results: A total of 508 children were recruited into the study; 252 received MgSO4 and 256 received placebo along with the standard treatment. There were no differences in baseline characteristics. There was a small, but statistically significant difference in ASS at T60 in those children who received nebulised MgSO4 {0.25 [95% confidence interval (CI) 0.02 to 0.48]; p = 0.034} and this difference was sustained for up to 240 minutes [0.20 (95% CI 0.01 to 0.40), p = 0.042]. The clinical significance of this gain is uncertain. Assessing treatment-covariate interactions, there is evidence of a larger effect in those children with more Severe Asthma exacerbations ( p = 0.034) and those with a shorter duration of symptoms ( p = 0.049). There were no significant differences in the secondary outcomes measured. Adverse events (AEs) were reported in 19% of children in the magnesium group and 20% in the placebo group. There were no clinically significant serious AEs in either group. The results of the base-case economic analyses are accompanied by considerable uncertainty, but suggest that, from an NHS and Personal Social Services perspective, the addition of magnesium to standard treatment may be cost-effective compared with standard treatment only. The results of economic evaluation show that the probability of magnesium being cost-effective is over 60% at cost-effectiveness thresholds of £1000 per unit decrement in ASS and £20,000 per quality-adjusted life-year (QALY) gained, respectively; it is noted that for some parameter variations this probability is much lower, reflecting the labile nature of the cost-effectiveness ratio in light of the small differences in benefits and costs shown in the trial and the relation between the main outcome measure (ASS) and preference based measures of quality of life used in cost-utility analysis (European Quality of Life-5 Dimensions; EQ-5D). Conclusions: This study supports the use of nebulised isotonic MgSO4 at the dose of 151 mg given three times in the first hour of treatment as an adjuvant to standard treatment when a child presents with an Acute episode of Severe Asthma. No harm is done by adding magnesium to salbutamol and ipratropium bromide, and in some individuals it may be clinically helpful. The response is likely to be more marked in those children with more Severe attacks and with a shorter duration of exacerbation. Although the study was not powered to demonstrate this fully, the data certainly support the hypotheses that nebulised magnesium has a greater clinical effect in children who have more Severe exacerbation with shorter duration of symptoms.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Summary Background Little evidence is available for the effect of nebulised magnesium sulphate (MgSO 4 ) in Acute Asthma in children. We assessed the effect of MgSO 4 treatment in children with Severe Acute Asthma. Methods In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO 4 (250 mmol/L; 151 mg per dose; MgSO 4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p Findings Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO 4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO 4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation Overall, nebulised isotonic MgSO 4 , given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO 2 Funding National Institute for Health Research Health Technology Assessment Programme.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Background: Little evidence is available for the effect of nebulised magnesium sulphate (MgSO4) in Acute Asthma in children. We assessed the effect of MgSO4 treatment in children with Severe Acute Asthma. Methods: In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO4 (250 mmol/L; 151 mg per dose; MgSO4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p<0·05 for a between-group difference, but regarded a between-group difference in ASS of 0·5 as the minimal clinically significant treatment effect. Analysis was done by intention to treat. This trial is registered with controlled-trials.com, number ISRCTN81456894. Findings: Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation: Overall, nebulised isotonic MgSO4, given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO2<92%) at presentation and those with preceding symptoms lasting less than 6 h.

John Lowe - One of the best experts on this subject based on the ideXlab platform.

  • economic evaluation of nebulized magnesium sulphate in Acute Severe Asthma in children
    International Journal of Technology Assessment in Health Care, 2014
    Co-Authors: Stavros Petrou, Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Iolo Doull, Kerenza Hood, Kamran Khan, Paula R Williamson
    Abstract:

    Objectives: The aim of this study was to estimate the cost-effectiveness of nebulized magnesium sulphate (MgSO4) in Acute Asthma in children from the perspective of the UK National Health Service and personal social services. Methods: An economic evaluation was conducted based on evidence from a randomized placebo controlled multi-center trial of nebulized MgSO4 in Severe Acute Asthma in children. Participants comprised 508 children aged 2–16 years presenting to an emergency department or a children's assessment unit with Severe Acute Asthma across thirty hospitals in the United Kingdom. Children were randomly allocated to receive nebulized salbutamol and ipratropium bromide mixed with either 2.5 ml of isotonic MgSO4 or 2.5 ml of isotonic saline on three occasions at 20-min intervals. Cost-effectiveness outcomes were constructed around the Yung Asthma Severity Score (ASS) after 60 min of treatment; whilst cost-utility outcomes were constructed around the quality-adjusted life-year (QALY) metric. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative cost-effectiveness thresholds for either: (i) a unit reduction in ASS; or (ii) an additional QALY. Results: MgSO4 had a 75.1 percent probability of being cost-effective at a GBP 1,000 (EUR 1,148) per unit decrement in ASS threshold, an 88.0 percent probability of being more effective (in terms of reducing the ASS) and a 36.6 percent probability of being less costly. MgSO4 also had a 67.6 percent probability of being cost-effective at a GBP 20,000 (EUR 22,957) per QALY gained threshold, an 8.5 percent probability of being more effective (in terms of generating increased QALYs) and a 69.1 percent probability of being less costly. Sensitivity analyses showed that the results of the economic evaluation were particularly sensitive to the methods used for QALY estimation. Conclusions: The probability of cost-effectiveness of nebulized isotonic MgSO4, given as an adjuvant to standard treatment of Severe Acute Asthma in children, is less than 70 percent across accepted cost-effectiveness thresholds for an additional QALY.

  • magnesium trial in children magnetic a randomised placebo controlled trial and economic evaluation of nebulised magnesium sulphate in Acute Severe Asthma in children
    Health Technology Assessment, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, Stavros Petrou, Iolo Doull, Kerenza Hood, Alison Boland, Paula R Williamson
    Abstract:

    Background: There are few data on the role of nebulised magnesium sulphate (MgSO4) in the management of Acute Asthma in children. Those studies that have been published are underpowered, and use different methods, interventions and comparisons. Thus, no firm conclusions can be drawn. Objectives: Does the use of nebulised MgSO4, when given as an adjunct to standard therapy in Acute Severe Asthma in children, result in a clinical improvement when compared with standard treatment alone? Design: Patients were randomised to receive three doses of MgSO4 or placebo, each combined with salbutamol and ipratropium bromide, for 1 hour. The Yung Asthma Severity Score (ASS) was measured at baseline, randomisation, and at 20, 40, 60 (T60), 120, 180 and 240 minutes after randomisation. Setting: Emergency departments and children's assessment units at 30 hospitals in the UK. Participants: Children aged 2-15 years with Acute Severe Asthma. Interventions: Patients were randomised to receive nebulised salbutamol 2.5 mg (ages 2-5 years) or 5 mg (ages ≥ 6 years) and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic MgSO4 (250 mmol/l, tonicity 289 mOsm; 151 mg per dose) or 2.5 ml of isotonic saline on three occasions at approximately 20-minute intervals. Main outcome measures: The primary outcome measure was the ASS after 1 hour of treatment. Secondary measures included 'stepping down' of treatment at 1 hour, number and frequency of additional salbutamol administrations, length of stay in hospital, requirement for intravenous bronchodilator treatment, and intubation and/or admission to a paediatric intensive care unit. Data on paediatric quality of life, time off school/nursery, health-care resource usage and time off work were collected 1 month after randomisation. Results: A total of 508 children were recruited into the study; 252 received MgSO4 and 256 received placebo along with the standard treatment. There were no differences in baseline characteristics. There was a small, but statistically significant difference in ASS at T60 in those children who received nebulised MgSO4 {0.25 [95% confidence interval (CI) 0.02 to 0.48]; p = 0.034} and this difference was sustained for up to 240 minutes [0.20 (95% CI 0.01 to 0.40), p = 0.042]. The clinical significance of this gain is uncertain. Assessing treatment-covariate interactions, there is evidence of a larger effect in those children with more Severe Asthma exacerbations ( p = 0.034) and those with a shorter duration of symptoms ( p = 0.049). There were no significant differences in the secondary outcomes measured. Adverse events (AEs) were reported in 19% of children in the magnesium group and 20% in the placebo group. There were no clinically significant serious AEs in either group. The results of the base-case economic analyses are accompanied by considerable uncertainty, but suggest that, from an NHS and Personal Social Services perspective, the addition of magnesium to standard treatment may be cost-effective compared with standard treatment only. The results of economic evaluation show that the probability of magnesium being cost-effective is over 60% at cost-effectiveness thresholds of £1000 per unit decrement in ASS and £20,000 per quality-adjusted life-year (QALY) gained, respectively; it is noted that for some parameter variations this probability is much lower, reflecting the labile nature of the cost-effectiveness ratio in light of the small differences in benefits and costs shown in the trial and the relation between the main outcome measure (ASS) and preference based measures of quality of life used in cost-utility analysis (European Quality of Life-5 Dimensions; EQ-5D). Conclusions: This study supports the use of nebulised isotonic MgSO4 at the dose of 151 mg given three times in the first hour of treatment as an adjuvant to standard treatment when a child presents with an Acute episode of Severe Asthma. No harm is done by adding magnesium to salbutamol and ipratropium bromide, and in some individuals it may be clinically helpful. The response is likely to be more marked in those children with more Severe attacks and with a shorter duration of exacerbation. Although the study was not powered to demonstrate this fully, the data certainly support the hypotheses that nebulised magnesium has a greater clinical effect in children who have more Severe exacerbation with shorter duration of symptoms.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Summary Background Little evidence is available for the effect of nebulised magnesium sulphate (MgSO 4 ) in Acute Asthma in children. We assessed the effect of MgSO 4 treatment in children with Severe Acute Asthma. Methods In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO 4 (250 mmol/L; 151 mg per dose; MgSO 4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p Findings Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO 4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO 4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation Overall, nebulised isotonic MgSO 4 , given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO 2 Funding National Institute for Health Research Health Technology Assessment Programme.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Background: Little evidence is available for the effect of nebulised magnesium sulphate (MgSO4) in Acute Asthma in children. We assessed the effect of MgSO4 treatment in children with Severe Acute Asthma. Methods: In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO4 (250 mmol/L; 151 mg per dose; MgSO4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p<0·05 for a between-group difference, but regarded a between-group difference in ASS of 0·5 as the minimal clinically significant treatment effect. Analysis was done by intention to treat. This trial is registered with controlled-trials.com, number ISRCTN81456894. Findings: Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation: Overall, nebulised isotonic MgSO4, given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO2<92%) at presentation and those with preceding symptoms lasting less than 6 h.

Stavros Petrou - One of the best experts on this subject based on the ideXlab platform.

  • economic evaluation of nebulized magnesium sulphate in Acute Severe Asthma in children
    International Journal of Technology Assessment in Health Care, 2014
    Co-Authors: Stavros Petrou, Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Iolo Doull, Kerenza Hood, Kamran Khan, Paula R Williamson
    Abstract:

    Objectives: The aim of this study was to estimate the cost-effectiveness of nebulized magnesium sulphate (MgSO4) in Acute Asthma in children from the perspective of the UK National Health Service and personal social services. Methods: An economic evaluation was conducted based on evidence from a randomized placebo controlled multi-center trial of nebulized MgSO4 in Severe Acute Asthma in children. Participants comprised 508 children aged 2–16 years presenting to an emergency department or a children's assessment unit with Severe Acute Asthma across thirty hospitals in the United Kingdom. Children were randomly allocated to receive nebulized salbutamol and ipratropium bromide mixed with either 2.5 ml of isotonic MgSO4 or 2.5 ml of isotonic saline on three occasions at 20-min intervals. Cost-effectiveness outcomes were constructed around the Yung Asthma Severity Score (ASS) after 60 min of treatment; whilst cost-utility outcomes were constructed around the quality-adjusted life-year (QALY) metric. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative cost-effectiveness thresholds for either: (i) a unit reduction in ASS; or (ii) an additional QALY. Results: MgSO4 had a 75.1 percent probability of being cost-effective at a GBP 1,000 (EUR 1,148) per unit decrement in ASS threshold, an 88.0 percent probability of being more effective (in terms of reducing the ASS) and a 36.6 percent probability of being less costly. MgSO4 also had a 67.6 percent probability of being cost-effective at a GBP 20,000 (EUR 22,957) per QALY gained threshold, an 8.5 percent probability of being more effective (in terms of generating increased QALYs) and a 69.1 percent probability of being less costly. Sensitivity analyses showed that the results of the economic evaluation were particularly sensitive to the methods used for QALY estimation. Conclusions: The probability of cost-effectiveness of nebulized isotonic MgSO4, given as an adjuvant to standard treatment of Severe Acute Asthma in children, is less than 70 percent across accepted cost-effectiveness thresholds for an additional QALY.

  • magnesium trial in children magnetic a randomised placebo controlled trial and economic evaluation of nebulised magnesium sulphate in Acute Severe Asthma in children
    Health Technology Assessment, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, Stavros Petrou, Iolo Doull, Kerenza Hood, Alison Boland, Paula R Williamson
    Abstract:

    Background: There are few data on the role of nebulised magnesium sulphate (MgSO4) in the management of Acute Asthma in children. Those studies that have been published are underpowered, and use different methods, interventions and comparisons. Thus, no firm conclusions can be drawn. Objectives: Does the use of nebulised MgSO4, when given as an adjunct to standard therapy in Acute Severe Asthma in children, result in a clinical improvement when compared with standard treatment alone? Design: Patients were randomised to receive three doses of MgSO4 or placebo, each combined with salbutamol and ipratropium bromide, for 1 hour. The Yung Asthma Severity Score (ASS) was measured at baseline, randomisation, and at 20, 40, 60 (T60), 120, 180 and 240 minutes after randomisation. Setting: Emergency departments and children's assessment units at 30 hospitals in the UK. Participants: Children aged 2-15 years with Acute Severe Asthma. Interventions: Patients were randomised to receive nebulised salbutamol 2.5 mg (ages 2-5 years) or 5 mg (ages ≥ 6 years) and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic MgSO4 (250 mmol/l, tonicity 289 mOsm; 151 mg per dose) or 2.5 ml of isotonic saline on three occasions at approximately 20-minute intervals. Main outcome measures: The primary outcome measure was the ASS after 1 hour of treatment. Secondary measures included 'stepping down' of treatment at 1 hour, number and frequency of additional salbutamol administrations, length of stay in hospital, requirement for intravenous bronchodilator treatment, and intubation and/or admission to a paediatric intensive care unit. Data on paediatric quality of life, time off school/nursery, health-care resource usage and time off work were collected 1 month after randomisation. Results: A total of 508 children were recruited into the study; 252 received MgSO4 and 256 received placebo along with the standard treatment. There were no differences in baseline characteristics. There was a small, but statistically significant difference in ASS at T60 in those children who received nebulised MgSO4 {0.25 [95% confidence interval (CI) 0.02 to 0.48]; p = 0.034} and this difference was sustained for up to 240 minutes [0.20 (95% CI 0.01 to 0.40), p = 0.042]. The clinical significance of this gain is uncertain. Assessing treatment-covariate interactions, there is evidence of a larger effect in those children with more Severe Asthma exacerbations ( p = 0.034) and those with a shorter duration of symptoms ( p = 0.049). There were no significant differences in the secondary outcomes measured. Adverse events (AEs) were reported in 19% of children in the magnesium group and 20% in the placebo group. There were no clinically significant serious AEs in either group. The results of the base-case economic analyses are accompanied by considerable uncertainty, but suggest that, from an NHS and Personal Social Services perspective, the addition of magnesium to standard treatment may be cost-effective compared with standard treatment only. The results of economic evaluation show that the probability of magnesium being cost-effective is over 60% at cost-effectiveness thresholds of £1000 per unit decrement in ASS and £20,000 per quality-adjusted life-year (QALY) gained, respectively; it is noted that for some parameter variations this probability is much lower, reflecting the labile nature of the cost-effectiveness ratio in light of the small differences in benefits and costs shown in the trial and the relation between the main outcome measure (ASS) and preference based measures of quality of life used in cost-utility analysis (European Quality of Life-5 Dimensions; EQ-5D). Conclusions: This study supports the use of nebulised isotonic MgSO4 at the dose of 151 mg given three times in the first hour of treatment as an adjuvant to standard treatment when a child presents with an Acute episode of Severe Asthma. No harm is done by adding magnesium to salbutamol and ipratropium bromide, and in some individuals it may be clinically helpful. The response is likely to be more marked in those children with more Severe attacks and with a shorter duration of exacerbation. Although the study was not powered to demonstrate this fully, the data certainly support the hypotheses that nebulised magnesium has a greater clinical effect in children who have more Severe exacerbation with shorter duration of symptoms.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Summary Background Little evidence is available for the effect of nebulised magnesium sulphate (MgSO 4 ) in Acute Asthma in children. We assessed the effect of MgSO 4 treatment in children with Severe Acute Asthma. Methods In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO 4 (250 mmol/L; 151 mg per dose; MgSO 4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p Findings Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO 4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO 4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation Overall, nebulised isotonic MgSO 4 , given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO 2 Funding National Institute for Health Research Health Technology Assessment Programme.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Background: Little evidence is available for the effect of nebulised magnesium sulphate (MgSO4) in Acute Asthma in children. We assessed the effect of MgSO4 treatment in children with Severe Acute Asthma. Methods: In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO4 (250 mmol/L; 151 mg per dose; MgSO4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p<0·05 for a between-group difference, but regarded a between-group difference in ASS of 0·5 as the minimal clinically significant treatment effect. Analysis was done by intention to treat. This trial is registered with controlled-trials.com, number ISRCTN81456894. Findings: Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation: Overall, nebulised isotonic MgSO4, given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO2<92%) at presentation and those with preceding symptoms lasting less than 6 h.

Ruwanthi Kolamunnagedona - One of the best experts on this subject based on the ideXlab platform.

  • economic evaluation of nebulized magnesium sulphate in Acute Severe Asthma in children
    International Journal of Technology Assessment in Health Care, 2014
    Co-Authors: Stavros Petrou, Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Iolo Doull, Kerenza Hood, Kamran Khan, Paula R Williamson
    Abstract:

    Objectives: The aim of this study was to estimate the cost-effectiveness of nebulized magnesium sulphate (MgSO4) in Acute Asthma in children from the perspective of the UK National Health Service and personal social services. Methods: An economic evaluation was conducted based on evidence from a randomized placebo controlled multi-center trial of nebulized MgSO4 in Severe Acute Asthma in children. Participants comprised 508 children aged 2–16 years presenting to an emergency department or a children's assessment unit with Severe Acute Asthma across thirty hospitals in the United Kingdom. Children were randomly allocated to receive nebulized salbutamol and ipratropium bromide mixed with either 2.5 ml of isotonic MgSO4 or 2.5 ml of isotonic saline on three occasions at 20-min intervals. Cost-effectiveness outcomes were constructed around the Yung Asthma Severity Score (ASS) after 60 min of treatment; whilst cost-utility outcomes were constructed around the quality-adjusted life-year (QALY) metric. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves at alternative cost-effectiveness thresholds for either: (i) a unit reduction in ASS; or (ii) an additional QALY. Results: MgSO4 had a 75.1 percent probability of being cost-effective at a GBP 1,000 (EUR 1,148) per unit decrement in ASS threshold, an 88.0 percent probability of being more effective (in terms of reducing the ASS) and a 36.6 percent probability of being less costly. MgSO4 also had a 67.6 percent probability of being cost-effective at a GBP 20,000 (EUR 22,957) per QALY gained threshold, an 8.5 percent probability of being more effective (in terms of generating increased QALYs) and a 69.1 percent probability of being less costly. Sensitivity analyses showed that the results of the economic evaluation were particularly sensitive to the methods used for QALY estimation. Conclusions: The probability of cost-effectiveness of nebulized isotonic MgSO4, given as an adjuvant to standard treatment of Severe Acute Asthma in children, is less than 70 percent across accepted cost-effectiveness thresholds for an additional QALY.

  • magnesium trial in children magnetic a randomised placebo controlled trial and economic evaluation of nebulised magnesium sulphate in Acute Severe Asthma in children
    Health Technology Assessment, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, Stavros Petrou, Iolo Doull, Kerenza Hood, Alison Boland, Paula R Williamson
    Abstract:

    Background: There are few data on the role of nebulised magnesium sulphate (MgSO4) in the management of Acute Asthma in children. Those studies that have been published are underpowered, and use different methods, interventions and comparisons. Thus, no firm conclusions can be drawn. Objectives: Does the use of nebulised MgSO4, when given as an adjunct to standard therapy in Acute Severe Asthma in children, result in a clinical improvement when compared with standard treatment alone? Design: Patients were randomised to receive three doses of MgSO4 or placebo, each combined with salbutamol and ipratropium bromide, for 1 hour. The Yung Asthma Severity Score (ASS) was measured at baseline, randomisation, and at 20, 40, 60 (T60), 120, 180 and 240 minutes after randomisation. Setting: Emergency departments and children's assessment units at 30 hospitals in the UK. Participants: Children aged 2-15 years with Acute Severe Asthma. Interventions: Patients were randomised to receive nebulised salbutamol 2.5 mg (ages 2-5 years) or 5 mg (ages ≥ 6 years) and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic MgSO4 (250 mmol/l, tonicity 289 mOsm; 151 mg per dose) or 2.5 ml of isotonic saline on three occasions at approximately 20-minute intervals. Main outcome measures: The primary outcome measure was the ASS after 1 hour of treatment. Secondary measures included 'stepping down' of treatment at 1 hour, number and frequency of additional salbutamol administrations, length of stay in hospital, requirement for intravenous bronchodilator treatment, and intubation and/or admission to a paediatric intensive care unit. Data on paediatric quality of life, time off school/nursery, health-care resource usage and time off work were collected 1 month after randomisation. Results: A total of 508 children were recruited into the study; 252 received MgSO4 and 256 received placebo along with the standard treatment. There were no differences in baseline characteristics. There was a small, but statistically significant difference in ASS at T60 in those children who received nebulised MgSO4 {0.25 [95% confidence interval (CI) 0.02 to 0.48]; p = 0.034} and this difference was sustained for up to 240 minutes [0.20 (95% CI 0.01 to 0.40), p = 0.042]. The clinical significance of this gain is uncertain. Assessing treatment-covariate interactions, there is evidence of a larger effect in those children with more Severe Asthma exacerbations ( p = 0.034) and those with a shorter duration of symptoms ( p = 0.049). There were no significant differences in the secondary outcomes measured. Adverse events (AEs) were reported in 19% of children in the magnesium group and 20% in the placebo group. There were no clinically significant serious AEs in either group. The results of the base-case economic analyses are accompanied by considerable uncertainty, but suggest that, from an NHS and Personal Social Services perspective, the addition of magnesium to standard treatment may be cost-effective compared with standard treatment only. The results of economic evaluation show that the probability of magnesium being cost-effective is over 60% at cost-effectiveness thresholds of £1000 per unit decrement in ASS and £20,000 per quality-adjusted life-year (QALY) gained, respectively; it is noted that for some parameter variations this probability is much lower, reflecting the labile nature of the cost-effectiveness ratio in light of the small differences in benefits and costs shown in the trial and the relation between the main outcome measure (ASS) and preference based measures of quality of life used in cost-utility analysis (European Quality of Life-5 Dimensions; EQ-5D). Conclusions: This study supports the use of nebulised isotonic MgSO4 at the dose of 151 mg given three times in the first hour of treatment as an adjuvant to standard treatment when a child presents with an Acute episode of Severe Asthma. No harm is done by adding magnesium to salbutamol and ipratropium bromide, and in some individuals it may be clinically helpful. The response is likely to be more marked in those children with more Severe attacks and with a shorter duration of exacerbation. Although the study was not powered to demonstrate this fully, the data certainly support the hypotheses that nebulised magnesium has a greater clinical effect in children who have more Severe exacerbation with shorter duration of symptoms.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Summary Background Little evidence is available for the effect of nebulised magnesium sulphate (MgSO 4 ) in Acute Asthma in children. We assessed the effect of MgSO 4 treatment in children with Severe Acute Asthma. Methods In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO 4 (250 mmol/L; 151 mg per dose; MgSO 4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p Findings Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO 4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO 4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation Overall, nebulised isotonic MgSO 4 , given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO 2 Funding National Institute for Health Research Health Technology Assessment Programme.

  • magnesium sulphate in Acute Severe Asthma in children magnetic a randomised placebo controlled trial
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Colin Powell, Ruwanthi Kolamunnagedona, John Lowe, A Boland, Stavros Petrou, Iolo Doull, Kerenza Hood, Paula R Williamson
    Abstract:

    Background: Little evidence is available for the effect of nebulised magnesium sulphate (MgSO4) in Acute Asthma in children. We assessed the effect of MgSO4 treatment in children with Severe Acute Asthma. Methods: In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2–16 years) with Severe Acute Asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO4 (250 mmol/L; 151 mg per dose; MgSO4 group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p<0·05 for a between-group difference, but regarded a between-group difference in ASS of 0·5 as the minimal clinically significant treatment effect. Analysis was done by intention to treat. This trial is registered with controlled-trials.com, number ISRCTN81456894. Findings: Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO4 and 256 to placebo. Mean ASS at 60 min was lower in the MgSO4 group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference −0·25, 95% CI −0·48 to −0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more Severe Asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Interpretation: Overall, nebulised isotonic MgSO4, given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with Acute Severe Asthma. However, the greatest clinical response was seen in children with more Severe attacks (SaO2<92%) at presentation and those with preceding symptoms lasting less than 6 h.