Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial.

ABSTRACT

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.