title: Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01415583.
authors.affiliation: Department of Otolaryngology, Naval Medical Center Portsmouth, Portsmouth, Virginia, USA.
authors.forename: Thomas Q
authors.initials: TQ
authors.lastname: Gallagher
authors.forename: Courtney
authors.initials: C
authors.lastname: Hill
authors.forename: Shilpa
authors.initials: S
authors.lastname: Ojha
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Ference
authors.forename: Donald G
authors.initials: DG
authors.lastname: Keamy
authors.forename: Michael
authors.initials: M
authors.lastname: Williams
authors.forename: Maynard
authors.initials: M
authors.lastname: Hansen
authors.forename: Rie
authors.initials: R
authors.lastname: Maurer
authors.forename: Corey
authors.initials: C
authors.lastname: Collins
authors.forename: Jennifer
authors.initials: J
authors.lastname: Setlur
authors.forename: Gregory G
authors.initials: GG
authors.lastname: Capra
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Brigger
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Hartnick
mesh_terms: D000293:Adolescent; D000932:Antiemetics / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003907:Dexamethasone / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019990:Perioperative Care; D019106:Postoperative Hemorrhage / Q000139:chemically induced*; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control; D011446:Prospective Studies; D012306:Risk; D012720:Severity of Illness Index; D014068:Tonsillectomy
chemical_list: D000932:Antiemetics; D003907:Dexamethasone