Effect of Adenotonsillectomy on middle ear status in children.

Objective: To determine the effects of Adenotonsillectomy as compared with watchful waiting on the middle ear status of children.

Study Design: Randomized controlled trial.

Methods: We recruited 300 children between 2 and 8 years of age who were selected for Adenotonsillectomy according to current medical practice. Excluded from the trial were children with very frequent throat infections (more than 6 per year) or obstructive sleep apnea. Participants were randomly assigned to either Adenotonsillectomy or watchful waiting. Main outcome measure was the percentage of children with unilateral or bilateral otitis media diagnosed at the scheduled follow-up visits according to an algorithm combining tympanometry and otoscopy.

Results: The percentages of children in the Adenotonsillectomy and watchful waiting group diagnosed with otitis media at baseline and at 3, 6, 12, 18, and 24 months were 27.7 versus 30.5, 16.8 versus 25.2, 18.3 versus 21.2, 12.3 versus 15.2, 17.6 versus 15.5, and 14.7 versus 10.3%, respectively (P < .10). In the subgroup of children selected for Adenotonsillectomy predominantly because of recurrent or persistent otitis media, hearing loss, or recurrent upper respiratory tract infections (n = 111) and in the subgroup of children diagnosed with otitis media at inclusion (n = 82), the occurrence of otitis media did not differ significantly between the Adenotonsillectomy and watchful waiting group during the entire follow-up period.

Conclusion: We conclude that in a large proportion of children selected for Adenotonsillectomy according to current medical practice, including those with otitis media or related complaints, no beneficial effect of Adenotonsillectomy on middle ear status is to be expected.

tonsillectomy or Adenotonsillectomy versus non surgical management for obstructive sleep disordered breathing in children

BACKGROUND: Obstructive sleep-disordered breathing (oSDB) is a condition that encompasses breathing problems when asleep, due to an obstruction of the upper airways, ranging in severity from simple snoring to obstructive sleep apnoea syndrome (OSAS). It affects both children and adults. In children, hypertrophy of the tonsils and adenoid tissue is thought to be the commonest cause of oSDB. As such, tonsillectomy – with or without adenoidectomy – is considered an appropriate first-line treatment for most cases of paediatric oSDB. OBJECTIVES: To assess the benefits and harms of tonsillectomy with or without adenoidectomy compared with non-surgical management of children with oSDB. SEARCH METHODS: We searched the Cochrane Register of Studies Online, PubMed, EMBASE, CINAHL, Web of Science, Clinicaltrials.gov, ICTRP and additional sources for published and unpublished trials. The date of the search was 5 March 2015. SELECTION CRITERIA: Randomised controlled trials comparing the effectiveness and safety of (adeno)tonsillectomy with non-surgical management in children with oSDB aged 2 to 16 years. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by The Cochrane Collaboration. MAIN RESULTS: Three trials (562 children) met our inclusion criteria. Two were at moderate to high risk of bias and one at low risk of bias. We did not pool the results because of substantial clinical heterogeneity. They evaluated three different groups of children: those diagnosed with mild to moderate OSAS by polysomnography (PSG) (453 children aged five to nine years; low risk of bias; CHAT trial), those with a clinical diagnosis of oSDB but with negative PSG recordings (29 children aged two to 14 years; moderate to high risk of bias; Goldstein) and children with Down syndrome or mucopolysaccharidosis (MPS) diagnosed with mild to moderate OSAS by PSG (80 children aged six to 12 years; moderate to high risk of bias; Sudarsan). Moreover, the trials included two different comparisons: Adenotonsillectomy versus no surgery (CHAT trial and Goldstein) or versus continuous positive airway pressure (CPAP) (Sudarsan). Disease-specific quality of life and/or symptom score (using a validated instrument): first primary outcomeIn the largest trial with lowest risk of bias (CHAT trial), at seven months, mean scores for those instruments measuring disease-specific quality of life and/or symptoms were lower (that is, better quality of life or fewer symptoms) in children receiving Adenotonsillectomy than in those managed by watchful waiting:- OSA-18 questionnaire (scale 18 to 126): 31.8 versus 49.5 (mean difference (MD) -17.7, 95% confidence interval (CI) -21.2 to -14.2);- PSQ-SRBD questionnaire (scale 0 to 1): 0.2 versus 0.5 (MD -0.3, 95% CI -0.31 to -0.26);- Modified Epworth Sleepiness Scale (scale 0 to 24): 5.1 versus 7.1 (MD -2.0, 95% CI -2.9 to -1.1).No data on this primary outcome were reported in the Goldstein trial.In the Sudarsan trial, the mean OSA-18 score at 12 months did not significantly differ between the Adenotonsillectomy and CPAP groups. The mean modified Epworth Sleepiness Scale scores did not differ at six months, but were lower in the surgery group at 12 months: 5.5 versus 7.9 (MD -2.4, 95% CI -3.1 to -1.7). Adverse events: second primary outcomeIn the CHAT trial, 15 children experienced a serious adverse event: 6/194 (3%) in the Adenotonsillectomy group and 9/203 (4%) in the control group (RD -1%, 95% CI -5% to 2%).No major complications were reported in the Goldstein trial.In the Sudarsan trial, 2/37 (5%) developed a secondary haemorrhage after Adenotonsillectomy, while 1/36 (3%) developed a rash on the nasal dorsum secondary to the CPAP mask (RD -3%, 95% CI -6% to 12%). Secondary outcomesIn the CHAT trial, at seven months, mean scores for generic caregiver-rated quality of life were higher in children receiving Adenotonsillectomy than in those managed by watchful waiting. No data on this outcome were reported by Sudarsan and Goldstein.In the CHAT trial, at seven months, more children in the surgery group had normalisation of respiratory events during sleep as measured by PSG than those allocated to watchful waiting: 153/194 (79%) versus 93/203 (46%) (RD 33%, 95% CI 24% to 42%). In the Goldstein trial, at six months, PSG recordings were similar between groups and in the Sudarsan trial resolution of OSAS (Apnoea/Hypopnoea Index score below 1) did not significantly differ between the Adenotonsillectomy and CPAP groups.In the CHAT trial, at seven months, neurocognitive performance and attention and executive function had not improved with surgery: scores were similar in both groups. In the CHAT trial, at seven months, mean scores for caregiver-reported ratings of behaviour were lower (that is, better behaviour) in children receiving Adenotonsillectomy than in those managed by watchful waiting, however, teacher-reported ratings of behaviour did not significantly differ.No data on these outcomes were reported by Goldstein and Sudarsan. AUTHORS’ CONCLUSIONS: In otherwise healthy children, without a syndrome, of older age (five to nine years), and diagnosed with mild to moderate OSAS by PSG, there is moderate quality evidence that Adenotonsillectomy provides benefit in terms of quality of life, symptoms and behaviour as rated by caregivers and high quality evidence that this procedure is beneficial in terms of PSG parameters. At the same time, high quality evidence indicates no benefit in terms of objective measures of attention and neurocognitive performance compared with watchful waiting. Furthermore, PSG recordings of almost half of the children managed non-surgically had normalised by seven months, indicating that physicians and parents should carefully weigh the benefits and risks of Adenotonsillectomy against watchful waiting in these children. This is a condition that may recover spontaneously over time.For non-syndromic children classified as having oSDB on purely clinical grounds but with negative PSG recordings, the evidence on the effects of Adenotonsillectomy is of very low quality and is inconclusive.Low-quality evidence suggests that Adenotonsillectomy and CPAP may be equally effective in children with Down syndrome or MPS diagnosed with mild to moderate OSAS by PSG.We are unable to present data on the benefits of Adenotonsillectomy in children with oSDB aged under five, despite this being a population in whom this procedure is often performed for this purpose.

Adenotonsillectomy or watchful waiting in patients with mild to moderate symptoms of throat infections or adenotonsillar hypertrophy a randomized comparison of costs and effects

Objective To evaluate the cost-effectiveness of Adenotonsillectomy compared with watchful waiting in Dutch children. Design Economic evaluation along with an open, randomized, controlled trial. Setting Multicenter, including 21 general and 3 university hospitals in the Netherlands. Participants Three hundred children aged 2 to 8 years were selected for Adenotonsillectomy according to routine medical practice. Excluded were children who had frequent throat infections and those with suspected obstructive sleep apnea. Main Outcome Measures Incremental cost-effectiveness in terms of costs per episode of fever, throat infection, and upper respiratory tract infection avoided. Results Annual costs incurred in the Adenotonsillectomy group were €803 (the average exchange rate for the US dollar in 2002 was $1.00 = €1.1, except toward the end of 2002 when $0.95 = €100) and €551 in the watchful waiting group (46% increase). During a median follow-up of 22 months, surgery compared with watchful waiting reduced the number of episodes of fever and throat infections by 0.21 per person-year (95% confidence interval, −0.12 to 0.54 and 0.06 to 0.36, respectively) and upper respiratory tract infections by 0.53 (95% confidence interval, 0.08 to 0.97) episodes. The incremental costs per episode avoided were €1136, €1187, and €465, respectively. Conclusions In children undergoing Adenotonsillectomy because of mild to moderate symptoms of throat infections or adenotonsillar hypertrophy, surgery resulted in a significant increase in costs without realizing relevant clinical benefit. Subgroups of children in whom surgery would be cost-effective may be identified in further research. Trial Registration isrctn.org Identifier:ISRCTN04973569

effect of Adenotonsillectomy on parent reported sleepiness in children with obstructive sleep apnea

STUDY OBJECTIVES: To describe parental reports of sleepiness and sleep duration in children with polysomnography (PSG)-confirmed obstructive sleep apnea (OSA) randomized to early Adenotonsillectomy (eAT) or watchful waiting with supportive care (WWSC) in the ChildHood Adenotonsillectomy Trial (CHAT). We hypothesized children with OSA would have a larger improvement in sleepiness 6 mo following eAT compared to WWSC. METHODS: Parents of children aged 5.0-9.9 y completed the Epworth Sleepiness Scale modified for children (mESS) and the Pediatric Sleep Questionnaire-Sleepiness Subscale (PSQ-SS). PSG was performed at baseline and at 7-mo endpoint. Children underwent early Adenotonsillectomy or WWSC. RESULTS: The mESS and PSQ-SS classified 24% and 53% of the sample as excessively sleepy, respectively. At baseline, mean mESS score was 7.4 ± 5.0 (SD) and mean PSQ-SS score was 0.44 ± 0.30. Sleepiness scores were higher in African American children; children with shorter sleep duration; older children; and overweight children. At endpoint, mean mESS score decreased by 2.0 ± 4.2 in the eAT group versus 0.3 ± 4.0 in the WWSC group (P < 0.0001); mean PSQ-SS score decreased 0.29 ± 0.40 in eAT versus 0.08 ± 0.40 in the WWSC group (P < 0.0001). Despite higher baseline sleepiness, African American children experienced similar improvement with Adenotonsillectomy than other children. Improvement in sleepiness was weakly associated with improved apnea-hypopnea index or oxygen desaturation indices, but not with change in other polysomnographic measures. CONCLUSIONS: Sleepiness assessed by parent report was prevalent; improved more after eAT than after WWSC; and was not strongly predicted by sleep disturbances identified by PSG. CLINICAL TRIAL REGISTRATION: Childhood Adenotonsillectomy Study for Children with OSA (CHAT). ClinicalTrials.gov Identifier #NCT00560859.

complications of Adenotonsillectomy for obstructive sleep apnea in school aged children

Introduction
Adenotonsillectomy is the treatment of choice for most children with obstructive sleep apnea syndrome, but can lead to complications. Current guidelines recommend that high-risk children be hospitalized after Adenotonsillectomy, but it is unclear which otherwise-healthy children will develop post-operative complications. We hypothesized that polysomnographic parameters would predict post-operative complications in children who participated in the Childhood Adenotonsillectomy (CHAT) study.

quality of life and obstructive sleep apnea symptoms after pediatric Adenotonsillectomy

BACKGROUND AND OBJECTIVES: Data from a randomized, controlled study of Adenotonsillectomy for obstructive sleep apnea syndrome (OSAS) were used to test the hypothesis that children undergoing surgery had greater quality of life (QoL) and symptom improvement than control subjects. The objectives were to compare changes in validated QoL and symptom measurements among children randomized to undergo Adenotonsillectomy or watchful waiting; to determine whether race, weight, or baseline OSAS severity influenced changes in QoL and symptoms; and to evaluate associations between changes in QoL or symptoms and OSAS severity. METHODS: Children aged 5 to 9.9 years with OSAS (N = 453) were randomly assigned to undergo Adenotonsillectomy or watchful waiting with supportive care. Polysomnography, the Pediatric Quality of Life inventory, the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire, the 18-item Obstructive Sleep Apnea QoL instrument, and the modified Epworth Sleepiness Scale were completed at baseline and 7 months. Changes in the QoL and symptom surveys were compared between arms. Effect modification according to race and obesity and associations between changes in polysomnographic measures and QoL or symptoms were examined. RESULTS: Greater improvements in most QoL and symptom severity measurements were observed in children randomized to undergo Adenotonsillectomy, including the parent-completed Pediatric Quality of Life inventory (effect size [ES]: 0.37), the 18-item Obstructive Sleep Apnea QoL instrument (ES: –0.93), the modified Epworth Sleepiness Scale score (ES: –0.42), and the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire (ES: –1.35). Effect modification was not observed by obesity or baseline severity but was noted for race in some symptom measures. Improvements in OSAS severity explained only a small portion of the observed changes. CONCLUSIONS: Adenotonsillectomy compared with watchful waiting resulted in significantly more improvements in parent-rated generic and OSAS-specific QoL measures and OSAS symptoms.

cognitive effects of Adenotonsillectomy for obstructive sleep apnea

OBJECTIVE: Research reveals mixed evidence for the effects of Adenotonsillectomy (AT) on cognitive tests in children with obstructive sleep apnea syndrome (OSAS). The primary aim of the study was to investigate effects of AT on cognitive test scores in the randomized Childhood Adenotonsillectomy Trial. METHODS: Children ages 5 to 9 years with OSAS without prolonged oxyhemoglobin desaturation were randomly assigned to watchful waiting with supportive care (n = 227) or early AT (eAT, n = 226). Neuropsychological tests were administered before the intervention and 7 months after the intervention. Mixed model analysis compared the groups on changes in test scores across follow-up, and regression analysis examined associations of these changes in the eAT group with changes in sleep measures. RESULTS: Mean test scores were within the average range for both groups. Scores improved significantly (P CONCLUSIONS: Small and selective effects of AT were observed on cognitive tests in children with OSAS without prolonged desaturation. Relative to evidence from Childhood Adenotonsillectomy Trial for larger effects of surgery on sleep, behavior, and quality of life, AT may have limited benefits in reversing any cognitive effects of OSAS, or these benefits may require more extended follow-up to become manifest.

end tidal carbon dioxide measurement during pediatric polysomnography signal quality association with apnea severity and prediction of neurobehavioral outcomes

To identify the role of end-tidal carbon dioxide (EtCO2) monitoring during polysomnography in evaluation of children with obstructive sleep apnea syndrome (OSAS), including the correlation of EtCO2 with other measures of OSAS and prediction of changes in cognition and behavior after Adenotonsillectomy.Analysis of screening and endpoint data from the Childhood Adenotonsillectomy Trial, a randomized, controlled, multicenter study comparing early Adenotonsillectomy (eAT) to watchful waiting/supportive care (WWSC) in children with OSAS.Multisite clinical referral settings.Children, ages 5.0 to 9.9 y with suspected sleep apnea.eAT or WWSC.Quality EtCO2 waveforms were present for ≥ 75% of total sleep time (TST) in 876 of 960 (91.3%) screening polysomnograms. Among the 322 children who were randomized, 55 (17%) met pediatric criteria for hypoventilation. The mean TST with EtCO2 > 50 mmHg was modestly correlated with apnea-hypopnea index (AHI) (r = 0.33; P 50 mmHg was higher in African American children than others. The TST with EtCO2 > 50 mmHg decreased significantly more after eAT than WWSC. In adjusted analyses, baseline TST with EtCO2 > 50 mmHg did not predict postoperative changes in cognitive and behavioral measurements.Among children with suspected obstructive sleep apnea syndrome, overnight end-tidal carbon dioxide (EtCO2) levels are weakly to modestly correlated with other polysomnographic indices and therefore provide independent information on hypoventilation. EtCO2 levels improve with Adenotonsillectomy but are not as responsive as AHI and do not provide independent prediction of cognitive or behavioral response to surgery.Childhood Adenotonsillectomy Study for Children with OSAS (CHAT). ClinicalTrials.gov Identifier #NCT00560859.

complications of Adenotonsillectomy for obstructive sleep apnea in school aged children

Introduction
Adenotonsillectomy is the treatment of choice for most children with obstructive sleep apnea syndrome, but can lead to complications. Current guidelines recommend that high-risk children be hospitalized after Adenotonsillectomy, but it is unclear which otherwise-healthy children will develop post-operative complications. We hypothesized that polysomnographic parameters would predict post-operative complications in children who participated in the Childhood Adenotonsillectomy (CHAT) study.