(HealthDay News) – Perioperative dexamethasone administration is not associated with more serious bleeding events in pediatric tonsillectomy patients, according to a study published in the Sept 26 issue of the Journal of the American Medical Association.
Lieutenant Commander Thomas Q. Gallagher, MC, from the Naval Medical Center in Portsmouth, VA, and colleagues conducted a multicenter, prospective, randomized, double-blind, placebo-controlled trial involving 314 children, aged 3–18 years, undergoing tonsillectomy without a history of bleeding disorder or recent corticosteroid medication use. The patients were randomly assigned to receive either a single perioperative dose of dexamethasone (0.5mg/kg; maximum dose, 20mg) or an equivalent volume of 0.9% saline (placebo group).
The researchers found that 17 patients (10.8%) in the dexamethasone group and 13 patients (8.2%) in the placebo group reported bleeding events. The rates of level I bleeding were 7% in the dexamethasone group and 4.5% in the placebo group (difference, 2.6%; upper limit 97.5% confidence interval [CI], 7.7%; P for noninferiority =0.17) in intention-to-treat analysis; for level II bleeding, rates were 1.9 and 3.2%, respectively (difference, −1.3%; upper limit 97.5% CI, 2.2%; P for noninferiority <0.001); and rates of level III bleeding were 1.9 and 0.6%, respectively (difference, 1.3%; upper limit 97.5% CI, 3.8%; P for noninferiority =0.002).
“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%,” the authors write.