Document Detail


Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial.
MedLine Citation:
PMID:  23011712     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CONTEXT: Corticosteroids are commonly given to children undergoing tonsillectomy to reduce postoperative nausea and vomiting; however, they might increase the risk of perioperative and postoperative hemorrhage.
OBJECTIVE: To determine the effect of dexamethasone on bleeding following tonsillectomy in children.
DESIGN, SETTING, AND PATIENTS: A multicenter, prospective, randomized, double-blind, placebo-controlled study at 2 tertiary medical centers of 314 children aged 3 to 18 years undergoing tonsillectomy without a history of bleeding disorder or recent corticosteroid medication use and conducted between July 15, 2010, and December 20, 2011, with 14-day follow-up. We tested the hypothesis that dexamethasone would not result in 5% more bleeding events than placebo using a noninferiority statistical design.
INTERVENTION: A single perioperative dose of dexamethasone (0.5 mg/kg; maximum dose, 20 mg), with an equivalent volume of 0.9% saline administered to the placebo group.
MAIN OUTCOME MEASURES: Rate and severity of posttonsillectomy hemorrhage in the 14-day postoperative period using a bleeding severity scale (level I, self-reported or parent-reported postoperative bleeding; level II, required inpatient admission for postoperative bleeding; or level III, required reoperation to control postoperative bleeding).
RESULTS: One hundred fifty-seven children (median [interquartile range] age, 6 [4-8] years) were randomized into each study group, with 17 patients (10.8%) in the dexamethasone group and 13 patients (8.2%) in the placebo group reporting bleeding events. In an intention-to-treat analysis, the rates of level I bleeding were 7.0% (n = 11) in the dexamethasone group and 4.5% (n = 7) in the placebo group (difference, 2.6%; upper limit 97.5% CI, 7.7%; P for noninferiority = .17); rates of level II bleeding were 1.9% (n = 3) and 3.2% (n = 5), respectively (difference, -1.3%; upper limit 97.5% CI, 2.2%; P for noninferiority < .001); and rates of level III bleeding were 1.9% (n = 3) and 0.6% (n = 1), respectively (difference, 1.3%; upper limit 97.5% CI, 3.8%; P for noninferiority = .002).
CONCLUSIONS: Perioperative dexamethasone administered during pediatric tonsillectomy was not associated with excessive, clinically significant level II or III bleeding events based on not having crossed the noninferior threshold of 5%. Increased subjective (level I) bleeding events caused by dexamethasone could not be excluded because the noninferiority threshold was crossed.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01415583.
Authors:
Thomas Q Gallagher; Courtney Hill; Shilpa Ojha; Elisabeth Ference; Donald G Keamy; Michael Williams; Maynard Hansen; Rie Maurer; Corey Collins; Jennifer Setlur; Gregory G Capra; Matthew T Brigger; Christopher J Hartnick
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  JAMA     Volume:  308     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-09-26     Completed Date:  2012-09-28     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1221-6     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01415583
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Antiemetics / adverse effects*,  therapeutic use
Child
Child, Preschool
Dexamethasone / adverse effects*,  therapeutic use
Double-Blind Method
Female
Humans
Male
Perioperative Care*
Postoperative Hemorrhage / chemically induced*
Postoperative Nausea and Vomiting / prevention & control
Prospective Studies
Risk
Severity of Illness Index
Tonsillectomy*
Chemical
Reg. No./Substance:
0/Antiemetics; 7S5I7G3JQL/Dexamethasone
Comments/Corrections
Comment In:
JAMA. 2013 Feb 6;309(5):437   [PMID:  23385256 ]
JAMA. 2013 Feb 6;309(5):437-8   [PMID:  23385257 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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