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Thomas R. Walters - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of Ketorolac tromethamine 0 5 and levocabastine 0 05 a multicenter comparison in patients with seasonal allergic conjunctivitis
Advances in Therapy, 2000Co-Authors: Peter C Donshik, David Pearlman, Jacob Pinnas, David Tinkelman, Joseph Tauber, Michael B Raizman, Thomas R. WaltersAbstract:This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of Ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and Ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of Ketorolac, levocabastine, or vehicle was instilled in each eye four times daily for 6 weeks. In the majority of efficacy variables, Ketorolac produced the greatest improvements, followed by levocabastine and vehicle. Ketorolac was significantly more effective (P<.05) than vehicle in reducing mean itching scores, palpebral hyperemia, bulbar hyperemia, and edema. Patients treated with Ketorolac reported significant improvements (P<.05) in their ability to sleep and to concentrate on work, compared with those who received vehicle. No significant differences were noted among the treatment groups in safety or tolerability. Ketorolac tromethamine 0.5% ophthalmic solution instilled four times daily is effective and safe in reducing the signs and symptoms of seasonal allergic conjunctivitis.
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Efficacy and safety of Ketorolac tromethamine 0.5% and levocabastine 0.05%: a multicenter comparison in patients with seasonal allergic conjunctivitis
Advances in Therapy, 2000Co-Authors: Peter C Donshik, David Pearlman, Jacob Pinnas, David Tinkelman, Joseph Tauber, Michael B Raizman, Thomas R. WaltersAbstract:This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of Ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and Ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of Ketorolac, levocabastine, or vehicle was instilled in each eye four times daily for 6 weeks. In the majority of efficacy variables, Ketorolac produced the greatest improvements, followed by levocabastine and vehicle. Ketorolac was significantly more effective (P
Peter C Donshik - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of Ketorolac tromethamine 0 5 and levocabastine 0 05 a multicenter comparison in patients with seasonal allergic conjunctivitis
Advances in Therapy, 2000Co-Authors: Peter C Donshik, David Pearlman, Jacob Pinnas, David Tinkelman, Joseph Tauber, Michael B Raizman, Thomas R. WaltersAbstract:This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of Ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and Ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of Ketorolac, levocabastine, or vehicle was instilled in each eye four times daily for 6 weeks. In the majority of efficacy variables, Ketorolac produced the greatest improvements, followed by levocabastine and vehicle. Ketorolac was significantly more effective (P<.05) than vehicle in reducing mean itching scores, palpebral hyperemia, bulbar hyperemia, and edema. Patients treated with Ketorolac reported significant improvements (P<.05) in their ability to sleep and to concentrate on work, compared with those who received vehicle. No significant differences were noted among the treatment groups in safety or tolerability. Ketorolac tromethamine 0.5% ophthalmic solution instilled four times daily is effective and safe in reducing the signs and symptoms of seasonal allergic conjunctivitis.
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Efficacy and safety of Ketorolac tromethamine 0.5% and levocabastine 0.05%: a multicenter comparison in patients with seasonal allergic conjunctivitis
Advances in Therapy, 2000Co-Authors: Peter C Donshik, David Pearlman, Jacob Pinnas, David Tinkelman, Joseph Tauber, Michael B Raizman, Thomas R. WaltersAbstract:This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of Ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and Ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of Ketorolac, levocabastine, or vehicle was instilled in each eye four times daily for 6 weeks. In the majority of efficacy variables, Ketorolac produced the greatest improvements, followed by levocabastine and vehicle. Ketorolac was significantly more effective (P
Dinshaw Punthakee - One of the best experts on this subject based on the ideXlab platform.
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Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial
Canadian Journal of Anesthesia Journal canadien d'anesthésie, 2013Co-Authors: James E. Paul, Manyat Nantha-aree, Norman Buckley, Ji Cheng, Lehana Thabane, Antonella Tidy, Justin Debeer, Mitchell Winemaker, David Wismer, Dinshaw PunthakeeAbstract:Objectif Cette étude a consisté à déterminer si la gabapentine, donnée en préopératoire et pendant deux jours après l’opération (en addition à de la morphine en analgésie contrôlée par le patient [ACP], de l’acétaminophène et du kétorolac), était efficace pour réduire les besoins en morphine ainsi que pour diminuer les scores de douleur par rapport à un placebo pour une arthroplastie totale du genou. Méthode Cette étude randomisée contrôlée à double insu a été réalisée dans un seul centre, auprès de patients subissant une arthroplastie totale du genou primaire. Tous les patients ont reçu 1000 mg d’acétaminophène et 15 mg de kétorolac po avant l’opération. En postopératoire, les patients ont reçu de la morphine en ACP, 1000 mg d’acétaminophène toutes les six heures et 15 mg de kétorolac po toutes les six heures. Les patients ont reçu soit 600 mg de gabapentine po en préopératoire suivis de 200 mg po aux huit heures durant deux jours, soit un placebo correspondant. Le critère d’évaluation principal était la consommation cumulée de morphine à 72 h après la chirurgie. Les critères d’évaluation secondaires étaient les scores de douleur et la satisfaction des patients. Résultats Le groupe gabapentine comptait 52 patients et le groupe placebo en comptait 49. La consommation cumulée moyenne de morphine à 72 h postopératoires était de 66,3 mg dans le groupe gabapentine et de 72,5 mg dans le groupe placebo (différence −6,2 mg; intervalle de confiance 95 % −29,1 à 16,8 mg; P = 0,59). Les scores moyens de douleur au repos, avec un mouvement passif ou avec un mouvement contre résistance, étaient semblables dans les deux groupes à des points dans le temps correspondants au cours des trois premiers jours postopératoires. En outre, les scores moyens de satisfaction des patients et la durée du séjour à l’hôpital étaient semblables dans les deux groupes. Conclusion La gabapentine 600 mg po en préopératoire suivie de 200 mg po toutes les huit heures pendant deux jours n’a aucun effet sur la consommation postopératoire de morphine, les scores de douleur, la satisfaction des patients ou la durée du séjour à l’hôpital. Cette étude est enregistrée sous ClinicalTrials.gov NCT01307202. Purpose This study assessed whether gabapentin given preoperatively and for two days postoperatively (in addition to patient-controlled analgesia [PCA] morphine, acetaminophen, and Ketorolac) is effective in reducing morphine requirements and moderating pain scores when compared with placebo for primary total knee arthroplasty. Methods This single-centre double-blind randomized controlled trial was undertaken in patients who underwent primary total knee arthroplasty. All subjects received acetaminophen 1,000 mg and Ketorolac 15 mg po preoperatively. Postoperatively, subjects received PCA morphine, acetaminophen 1,000 mg every six hours, and Ketorolac 15 mg po every six hours. Subjects received either gabapentin 600 mg po preoperatively followed by 200 mg po every eight hours for two days or matching placebo. The primary outcome was cumulative morphine consumption at 72 hr following surgery. Secondary outcome measures included pain scores and patient satisfaction. Results There were 52 subjects in the gabapentin group and 49 subjects in the placebo group. The average cumulative morphine consumption at 72 hr postoperatively was 66.3 mg in the gabapentin group and 72.5 mg in the placebo group (difference −6.2 mg; 95% confidence interval −29.1 to 16.8 mg; P = 0.59). Mean pain scores at rest, with passive movement, or with weight bearing were similar in both groups at corresponding time periods for the first three days following surgery. In addition, mean patient satisfaction scores and hospital length of stay were similar in the two groups. Conclusion Gabapentin 600 mg po given preoperatively followed by 200 mg po every eight hours for two days has no effect on postoperative morphine consumption, pain scores, patient satisfaction, or length of hospital stay. This trial is registered at ClinicalTrials.gov NCT01307202.
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Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial
Canadian Journal of Anesthesia Journal canadien d'anesthésie, 2013Co-Authors: James E. Paul, Manyat Nantha-aree, Norman Buckley, Ji Cheng, Lehana Thabane, Antonella Tidy, Justin Debeer, Mitchell Winemaker, David Wismer, Dinshaw PunthakeeAbstract:Objectif Cette étude a consisté à déterminer si la gabapentine, donnée en préopératoire et pendant deux jours après l’opération (en addition à de la morphine en analgésie contrôlée par le patient [ACP], de l’acétaminophène et du kétorolac), était efficace pour réduire les besoins en morphine ainsi que pour diminuer les scores de douleur par rapport à un placebo pour une arthroplastie totale du genou. Méthode Cette étude randomisée contrôlée à double insu a été réalisée dans un seul centre, auprès de patients subissant une arthroplastie totale du genou primaire. Tous les patients ont reçu 1000 mg d’acétaminophène et 15 mg de kétorolac po avant l’opération. En postopératoire, les patients ont reçu de la morphine en ACP, 1000 mg d’acétaminophène toutes les six heures et 15 mg de kétorolac po toutes les six heures. Les patients ont reçu soit 600 mg de gabapentine po en préopératoire suivis de 200 mg po aux huit heures durant deux jours, soit un placebo correspondant. Le critère d’évaluation principal était la consommation cumulée de morphine à 72 h après la chirurgie. Les critères d’évaluation secondaires étaient les scores de douleur et la satisfaction des patients. Résultats Le groupe gabapentine comptait 52 patients et le groupe placebo en comptait 49. La consommation cumulée moyenne de morphine à 72 h postopératoires était de 66,3 mg dans le groupe gabapentine et de 72,5 mg dans le groupe placebo (différence −6,2 mg; intervalle de confiance 95 % −29,1 à 16,8 mg; P = 0,59). Les scores moyens de douleur au repos, avec un mouvement passif ou avec un mouvement contre résistance, étaient semblables dans les deux groupes à des points dans le temps correspondants au cours des trois premiers jours postopératoires. En outre, les scores moyens de satisfaction des patients et la durée du séjour à l’hôpital étaient semblables dans les deux groupes. Conclusion La gabapentine 600 mg po en préopératoire suivie de 200 mg po toutes les huit heures pendant deux jours n’a aucun effet sur la consommation postopératoire de morphine, les scores de douleur, la satisfaction des patients ou la durée du séjour à l’hôpital. Cette étude est enregistrée sous ClinicalTrials.gov NCT01307202. Purpose This study assessed whether gabapentin given preoperatively and for two days postoperatively (in addition to patient-controlled analgesia [PCA] morphine, acetaminophen, and Ketorolac) is effective in reducing morphine requirements and moderating pain scores when compared with placebo for primary total knee arthroplasty. Methods This single-centre double-blind randomized controlled trial was undertaken in patients who underwent primary total knee arthroplasty. All subjects received acetaminophen 1,000 mg and Ketorolac 15 mg po preoperatively. Postoperatively, subjects received PCA morphine, acetaminophen 1,000 mg every six hours, and Ketorolac 15 mg po every six hours. Subjects received either gabapentin 600 mg po preoperatively followed by 200 mg po every eight hours for two days or matching placebo. The primary outcome was cumulative morphine consumption at 72 hr following surgery. Secondary outcome measures included pain scores and patient satisfaction. Results There were 52 subjects in the gabapentin group and 49 subjects in the placebo group. The average cumulative morphine consumption at 72 hr postoperatively was 66.3 mg in the gabapentin group and 72.5 mg in the placebo group (difference −6.2 mg; 95% confidence interval −29.1 to 16.8 mg; P = 0.59). Mean pain scores at rest, with passive movement, or with weight bearing were similar in both groups at corresponding time periods for the first three days following surgery. In addition, mean patient satisfaction scores and hospital length of stay were similar in the two groups. Conclusion Gabapentin 600 mg po given preoperatively followed by 200 mg po every eight hours for two days has no effect on postoperative morphine consumption, pain scores, patient satisfaction, or length of hospital stay. This trial is registered at ClinicalTrials.gov NCT01307202.
Karel Allegaert - One of the best experts on this subject based on the ideXlab platform.
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impact of enantiomer specific changes in pharmacokinetics between infants and adults on the target concentration of racemic Ketorolac a pooled analysis
British Journal of Clinical Pharmacology, 2020Co-Authors: Karel Allegaert, Michael E Cloesmeijer, Michiel J Van Esdonk, Anne M Lynn, Anne Smits, Dick Tibboel, Youssef Daali, Klaus T OlkkolaAbstract:AIMS: Ketorolac is a non-steroidal anti-inflammatory racemic drug with analgesic effects only attributed to its S-enantiomer. The aim of this study is to quantify enantiomer-specific maturational pharmacokinetics (PK) of Ketorolac and investigate if the contribution of both enantiomers to the total Ketorolac concentration remains equal between infants and adults or if a change in target racemic concentration should be considered when applied to infants. METHODS: Data were pooled from 5 different studies in adults, children, and infants, with 1020 plasma concentrations following single intravenous Ketorolac administration. An allometry-based enantiomer-specific population PK model was developed with NONMEM 7.3. Simulations were performed in typical adults and infants to investigate differences in S- and R-Ketorolac exposure. RESULTS: S- and R-Ketorolac PK were best described with a 3- and a 2-compartment model respectively. The allometry-based PK parameters accounted for changes between populations. No maturation function of Ketorolac clearance could be identified. All model parameters were estimated with adequate precision (relative standard error <50%). Single dose simulations showed that a previously established analgesic concentration at half maximal effect (EC50-racemic ) in adults of 0.37 mg/L, had a mean S-Ketorolac concentration of 0.057 mg/L, but a mean S-Ketorolac concentration of 0.046 mg/L in infants. To match the effective adult S-Ketorolac-concentration (0.057 mg/L) in typical infants, the EC50-racemic should be increased 0.41 mg/L. CONCLUSION: Enantiomer-specific changes in Ketorolac PK yields different concentrations and S- and R-Ketorolac ratio's between infants and adults at identical racemic concentrations. These PK findings should be considered when studies on maturational pharmacodynamics are considered.
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p67 impact of enantiomer specific maturational changes in pharmacokinetics on the racemic Ketorolac target trough concentration
Archives of Disease in Childhood, 2019Co-Authors: Michael E Cloesmeijer, Karel Allegaert, Michiel J Van Esdonk, Anne M Lynn, Anne Smits, Dick Tibboel, Youssef Daali, Klaus T Olkkola, Ehj KrekelsAbstract:Introduction Ketorolac is a racemic drug with analgesic effects specific to its S-enantiomer. This study aimed to describe enantiomer-specific maturational pharmacokinetics (PK). Simulations were performed to describe how S-Ketorolac exposure in infants differs from adults, and how this affects the adult racemic analgesic trough threshold EC50 (EC50thr-adult, 0.37 mg/L) in infants (EC50thr-infant)when the same S-target is applied. Methods A population PK analysis (NONMEM 7.3) was performed based on 1020 plasma samples from 5 studies including 80 patients (adults, children, infants) following single intravenous Ketorolac administration. Results S-Ketorolac PK was best described with a 2-compartment model in infants and 3-compartment model in adults, while R-Ketorolac PK was best described with a 2-compartment model in all. S-Ketorolac clearance [mean population value: 3.45 L/h/56 kg] and central volume of distribution (V1) [4.27 L/56kg] increased exponentially with bodyweight (0.75, 0.59 respectively). R-Ketorolac clearance [0.93 L/h/56kg], peripheral volume of distribution (V2) and inter-compartmental clearance (Q) increased exponentially with bodyweight (0.62, 1.20, 0.76 respectively), V1 [4.11 L/56kg] linearly with bodyweight. Simulations revealed EC50thr-adult (0.37 mg/L) contained 0.048 mg/L S-Ketorolac as mean in typical adults (BW 48.6–99.6 kg), while EC50thr-adult contained 0.032–0.036 mg/L S-Ketorolac in typical infants (BW 5.3–10.6 kg). To reach adult S-enantiomer concentration (0.048 mg/L) in typical infants (BW 5.3–10.6 kg), EC50thr-infant should be 0.49–0.46 mg/L, respectively. Conclusion Enantiomer-specific maturational PK of Ketorolac were described. Subsequent simulations displayed differences in proportion of S- and R-Ketorolac on the racemic threshold EC50. A The same S-Ketorolac concentration necessitates a higher EC50thr-infant to EC50thr-adult. Disclosure(s) Nothing to disclose
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Determination of Racemic Ketorolac, Ketorolac Enantiomers and Their Metabolites in Human Plasma and Urine by LC–UV, Applied in Clinical Study During and After Pregnancy
Chromatographia, 2014Co-Authors: Aida Kulo, Jan Hoon, Nedzad Mulabegovic, Karel Allegaert, Svjetlana Loga-zec, Rene VerbesseltAbstract:In order to enhance the sensitivity and to develop a faster direct method for plasma and urine quantification of racemic Ketorolac, its metabolites (p-hydroxy-Ketorolac and Ketorolac glucuronides) and Ketorolac enantiomers, we developed an extraction procedure based on solid-phase extraction combined with specific and fast chromatographic separation. Extraction and chromatography resulted in cleaner chromatograms without interfering compounds. In both plasma and urine, linearity of the standard curves for racemic Ketorolac and p-hydroxy-Ketorolac was validated in the concentration range 0.025–10 mg L−1, while for Ketorolac enantiomers in the concentration range 0.025–5 mg L−1. The lower limit of quantification was two times lower than in earlier described methods. The developed method was suitable for direct quantification of racemic Ketorolac, p-hydroxy-Ketorolac and Ketorolac enantiomers in plasma and urine samples in women at delivery and in postpartum, enabling us to document significant intra-individual differences in pharmacokinetics between these physiological states.
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The impact of pregnancy on urinary Ketorolac metabolites after single intravenous bolus
European Journal of Drug Metabolism and Pharmacokinetics, 2013Co-Authors: Aida Kulo, Sarah Hendrickx, Jan Hoon, Nedzad Mulabegovic, Kristel Calsteren, Rene Verbesselt, Karel AllegaertAbstract:Compared to female volunteers or postpartum, Ketorolac clearance is higher at delivery. To explore the alterations that explain this higher clearance, urinary Ketorolac metabolites collected at delivery ( n = 40) were compared to female volunteers (unpaired, n = 8) or postpartum (paired, n = 8) following intravenous administration of 30 mg Ketorolac tromethamine. A mean 38 (SD 9) % of the Ketorolac dose was retrieved in 8-h urine collections. This was based on mean portions of 56 (20), 10 (14) and 33 (12) % for free Ketorolac, Ketorolac-glucuronide and p -hydroxy-Ketorolac, respectively. The mean Ketorolac-glucuronide portion at delivery (5 %) was lower compared to female volunteers (21 %) or postpartum (21 %) ( p = 0.003 and p = 0.002, respectively). Similarly, there was a difference in mean portion of free urinary Ketorolac at delivery when compared to healthy female volunteers (60–45 %, p = 0.046). Using paired statistics, the mean portion of total urinary Ketorolac was lower (62–73 %, p = 0.015) while the portion retrieved as p -hydroxy-Ketorolac was significantly higher at delivery compared to postpartum (38–28 %, p = 0.031). The differences in urine metabolites suggest that the increased Ketorolac clearance at delivery is in part explained by increased metabolic clearance to p -hydroxy-Ketorolac, reflecting increased oxidation activity.
James E Lingeman - One of the best experts on this subject based on the ideXlab platform.
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a novel drug eluting ureteral stent a prospective randomized multicenter clinical trial to evaluate the safety and effectiveness of a Ketorolac loaded ureteral stent
The Journal of Urology, 2009Co-Authors: Amy E Krambeck, Robert S Walsh, John D Denstedt, Glenn M Preminger, John C Evans, James E LingemanAbstract:Purpose: We evaluated the short-term safety and efficacy of a Ketorolac loaded ureteral stent compared to a standard stent (control).Materials and Methods: In this prospective, multicenter, double-blind study patients were randomized 1:1 to Ketorolac loaded or control stents after ureteroscopy. The primary end point was an intervention for pain defined as unscheduled physician contact, change in pain medication or early stent removal. Secondary end points included medication use and pain visual analog score. A total of 20 patients underwent serum safety testing for Ketorolac levels.Results: None of the safety cohort had detectable serum Ketorolac levels. Among the 276 patients there was no difference in primary (9.0% Ketorolac loaded vs 7.0% control, p = 0.66) or secondary (22.6% Ketorolac loaded vs 25.2% control, p = 0.67) intervention rates. Mean pain pill count at day 3 was lower in the Ketorolac loaded stent group than in the control group (p <0.05). A higher number (p = 0.057) of patients with ketoro...
