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Double-Blind Randomized Placebo-Controlled Trial of Single-Dose Intravenous Acetaminophen for Pain Associated With Adenotonsillectomy in Pediatric Patients With Sleep-Disordered Breathing.

ABSTRACT: OBJECTIVES:Adequate pain control is an important component in the postoperative outcome for pediatric adenotonsillectomy patients with sleep-disordered breathing (SDB). Intravenous acetaminophen appears to be a favorable analgesic adjunct owing to its predictable pharmacokinetics and opioid-sparing effects; however, its role in pediatric adenotonsillectomy pain management remains unclear. METHODS:In this prospective, randomized, double-blinded, controlled study, subjects with the diagnosis of SDB, aged 2 to 8 years, who required extended postoperative admission, received intravenous acetaminophen (15 mg/kg) or saline placebo intraoperatively in addition to morphine (0.1 mg/kg) for postoperative surgical analgesia. Pain scores in the postanesthesia care unit (PACU) using the FLACC (Faces, Leg, Activity, Cry, Consolability) score were used to determine the need for supplemental analgesic agents in the PACU. The PACU time and time to the first request for pain medication on the inpatient ward were also measured. RESULTS:A total of 239 patients were included in the final data analysis (118 in the intravenous acetaminophen group and 121 in the saline placebo group). The 2 groups did not differ in the proportion of patients reaching FLACC scores = 4 in the PACU (p = 0.223); mean FLACC scores in the PACU (p = 0.336); mean PACU time (p = 0.883); or time to requesting pain medication on the inpatient ward (p = 0.640). CONCLUSIONS:A single intraoperative dose of intravenous acetaminophen did not alter the postoperative course of pediatric patients with SDB following adenotonsillectomy.

SUBMITTER: Thung AK

PROVIDER: S-EPMC5640301 | biostudies-literature | 2017 Sep-Oct

REPOSITORIES: biostudies-literature

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Double-Blind Randomized Placebo-Controlled Trial of Single-Dose Intravenous Acetaminophen for Pain Associated With Adenotonsillectomy in Pediatric Patients With Sleep-Disordered Breathing.

Thung Arlyne K AK Elmaraghy Charles A CA Barry N'Diris N Tumin Dmitry D Jatana Kris R KR Rice Julie J Raman Vidya V Bhalla Tarun T Martin David P DP Corridore Marco M Tobias Joseph D JD

The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG 20170901 5

<h4>Objectives</h4>Adequate pain control is an important component in the postoperative outcome for pediatric adenotonsillectomy patients with sleep-disordered breathing (SDB). Intravenous acetaminophen appears to be a favorable analgesic adjunct owing to its predictable pharmacokinetics and opioid-sparing effects; however, its role in pediatric adenotonsillectomy pain management remains unclear.<h4>Methods</h4>In this prospective, randomized, double-blinded, controlled study, subjects with the ...[more]

PMID: 29042835

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Project description:INTRODUCTION:Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused. METHODS AND ANALYSIS:The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0-12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study's coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm. ETHICS AND DISSEMINATION:The study protocol was approved by the institutional review board (IRB) at Children's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community. TRIAL REGISTRATION NUMBER:NCT02562040; Pre-results.

Project description:Study objectivesObstructive sleep apnea is associated with neurobehavioral dysfunction, but the relationship between disease severity as measured by the apnea-hypopnea index and neurobehavioral morbidity is unclear. The objective of our study is to compare the neurobehavioral morbidity of mild sleep-disordered breathing versus obstructive sleep apnea.MethodsChildren 3-12 years old recruited for mild sleep-disordered breathing (snoring with obstructive apnea-hypopnea index < 3) into the Pediatric Adenotonsillectomy Trial for Snoring were compared to children 5-9 years old recruited for obstructive sleep apnea (obstructive apnea-hypopnea 2-30) into the Childhood Adenotonsillectomy Trial. Baseline demographic, polysomnographic, and neurobehavioral outcomes were compared using univariable and multivariable analysis.ResultsThe sample included 453 participants with obstructive sleep apnea (median obstructive apnea-hypopnea index 5.7) and 459 participants with mild sleep-disordered breathing (median obstructive apnea-hypopnea index 0.5). By polysomnography, participants with obstructive sleep apnea had poorer sleep efficiency and more arousals. Children with mild sleep-disordered breathing had more abnormal executive function scores (adjusted odds ratio 1.96, 95% CI 1.30-2.94) compared to children with obstructive sleep apnea. There were also elevated Conners scores for inattention (adjusted odds ratio 3.16, CI 1.98-5.02) and hyperactivity (adjusted odds ratio 2.82, CI 1.83-4.34) in children recruited for mild sleep-disordered breathing.ConclusionsAbnormal executive function, inattention, and hyperactivity were more common in symptomatic children recruited into a trial for mild sleep-disordered breathing compared to children recruited into a trial for obstructive sleep apnea. Young, snoring children with only minimally elevated apnea-hypopnea levels may still be at risk for deficits in executive function and attention.Trial registrationPediatric Adenotonsillectomy for Snoring (PATS), NCT02562040; Childhood Adenotonsillectomy Trial (CHAT), NCT00560859.

Project description:Study objectivesTo evaluate the prevalence of craniofacial/orthodontic abnormalities and oral dysfunctions in a population of children with persistent sleep-disordered breathing despite adenotonsillectomy.MethodsMedical charts of 4,000 children with sleep-disordered breathing operated on in a tertiary hospital were retrospectively reviewed. Patients reporting persistent sleep-disordered breathing symptoms were invited to an orthodontic/myofunctional evaluation following the Sleep Clinical Score), followed by a 1-night ambulatory type III sleep study.ResultsOne hundred nonsyndromic symptomatic patients were examined (mean age 8.8 ± 3.5 years), from 1 to 12 years after surgery (mean 4.6 ± 3.1 years); 24% were overweight/obese; 69 had a sleep study. Although prevalent, oronasal abnormalities and malocclusions were not specifically associated with pathological sleep parameters (cartilage hypotonia 18%, septal deviation 5%, short lingual frenulum 40%). Malocclusions were associated with a higher respiratory event index in children under 8 years only, whereas an impaired nasal dilator reflex and tongue immaturity were associated with an increased obstructive respiratory event index in all patients (1.72 ± 2.29 vs 0.72 ± 1.22 events/h, P = .011) and Respiratory Event Index, respectively (3.63 ± 3.63 vs 1.19 ± 1.19 events/h). Male sex, phenotype, nasal obstruction, oral breathing, and young age at surgery (< 3 years) were significantly related to higher respiratory event index. Using the Sleep Clinical Score > 6.5 cut-off, patients with persistent sleep apnea were significantly distinct from chronic snoring (2.72 ± 2.67 vs 0.58 ± 0.55, P < .01).ConclusionsOronasal anatomical and functional abnormalities were quite prevalent and various in persistent sleep-disordered breathing after adenotonsillectomy. Nasal disuse and tongue motor immaturity were associated with a higher obstructive respiratory event index in the long term, whereas craniofacial risk factors might have a more pronounced impact at younger age.

Project description:ObjectiveTo examine the association between sleep-disordered breathing and stroke outcomes, and determine the contribution of sleep-disordered breathing to outcome disparities in Mexican Americans.MethodsIschemic stroke patients (n = 995), identified from the population-based Brain Attack Surveillance in Corpus Christi Project (2010-2015), were offered participation in a sleep-disordered breathing study including a home sleep apnea test (ApneaLink Plus). Sleep-disordered breathing (respiratory event index ≥10) was determined soon after stroke. Neurologic, functional, cognitive, and quality of life outcomes were assessed at 90 days poststroke. Regression models were used to assess associations between sleep-disordered breathing and outcomes, adjusted for sociodemographics, prestroke function and cognition, health-risk behaviors, stroke severity, and vascular risk factors.ResultsMedian age was 67 years (interquartile range [IQR] = 59-78); 62.1% were Mexican American. Median respiratory event index was 14 (IQR = 6-25); 62.8% had sleep-disordered breathing. Sleep-disordered breathing was associated with worse functional outcome (mean difference in activities of daily living/instrumental activities of daily living score = 0.15, 95% confidence interval [CI] = 0.01-0.28) and cognitive outcome (mean difference in modified Mini-Mental State Examination = -2.66, 95% CI = -4.85 to -0.47) but not neurologic or quality of life outcomes. Sleep-disordered breathing accounted for 9 to 10% of ethnic differences in functional and cognitive outcome and was associated with cognitive outcome more strongly for Mexican Americans (β = -3.97, 95% CI = -6.63 to -1.31) than non-Hispanic whites (β = -0.40, 95% CI = -4.18 to 3.39, p-interaction = 0.15).InterpretationSleep-disordered breathing is associated with worse functional and cognitive function at 90 days poststroke. These outcomes are reasonable endpoints for future trials of sleep-disordered breathing treatment in stroke. If effective, sleep-disordered breathing treatment may somewhat lessen ethnic stroke outcome disparities. ANN NEUROL 2019;86:241-250.

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Double-Blind Randomized Placebo-Controlled Trial of Single-Dose Intravenous Acetaminophen for Pain Associated With Adenotonsillectomy in Pediatric Patients With Sleep-Disordered Breathing.

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Double-Blind Randomized Placebo-Controlled Trial of Single-Dose Intravenous Acetaminophen for Pain Associated With Adenotonsillectomy in Pediatric Patients With Sleep-Disordered Breathing.

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