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Gallagher LTQ, Hill C, Ojha S, et al. Perioperative Dexamethasone Administration and Risk of Bleeding Following Tonsillectomy in Children: A Randomized Controlled Trial. JAMA. 2012;308(12):1221–1226. doi:10.1001/2012.jama.11575
Author Affiliations: Department of Otolaryngology, Naval Medical Center Portsmouth, Portsmouth, Virginia (Dr Gallagher); Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (Dr Hill); Departments of Otolaryngology (Drs Ojha, Keamy, Williams, Hansen, Setlur, and Hartnick) and Anesthesiology (Dr Collins), Massachusetts Eye and Ear Infirmary, Boston; Department of Otolaryngology, Northwestern University, Chicago, Illinois (Dr Ference); Brigham and Women's Hospital, Boston, Massachusetts (Ms Maurer); and Department of Otolaryngology, Naval Medical Center San Diego, San Diego, California (Drs Capra and Brigger).
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
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