Dexamethasone for the treatment of sore throat in children with suspected infectious mononucleosis: a randomized, double-blind, placebo-controlled, clinical trial

Arch Pediatr Adolesc Med. 2004 Mar;158(3):250-4. doi: 10.1001/archpedi.158.3.250.

Abstract

Objective: To evaluate the efficacy of a single oral dose of dexamethasone for pain relief in acute exudative pharyngitis associated with infectious mononucleosis.

Methods: We conducted a randomized, double-blind, placebo-controlled pediatric emergency department-based clinical trial. Patients aged between 8 and 18 years with a sore throat from clinically suspected infectious mononucleosis were eligible. Patients were randomized to receive either an oral dose of 0.3 mg/kg (maximum, 15 mg) of dexamethasone or a placebo. Patients completed a diary of symptoms and rated their pain on a visual analog scale from 0 to 100 mm at 0 hours, 12 hours, 24 hours, 48 hours, 72 hours, and on day 7. An improvement of 20 mm from baseline on the visual analog scale was evaluated as the primary end point.

Results: Twenty patients were recruited in each group; mean +/- SD age was 13.5 +/- 2.8 years. In comparison with the placebo group, a significantly greater proportion of patients given dexamethasone achieved pain relief within the first 12 hours (12/20 vs 5/19; P =.03). On further follow-up, the proportions achieving pain relief were similar between groups: 11 of 20 vs 6 of 20 at 24 hours (P =.10); 11 of 20 vs 11 of 20 at 48 hours (P>.99); 15 of 20 vs 15 of 19 at 72 hours (P =.93); and 18 of 19 vs 19 of 20 at day 7 (P>.99), with dexamethasone vs placebo, respectively.

Conclusions: The short-lived relief of pain in acute exudative pharyngitis in children with suspected infectious mononucleosis may suggest that a single oral dose of dexamethasone may not be sufficient and that additional doses may be necessary for ensuring lasting relief.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / therapeutic use
  • Child
  • Dexamethasone / administration & dosage*
  • Dexamethasone / therapeutic use
  • Double-Blind Method
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / therapeutic use
  • Humans
  • Infectious Mononucleosis / complications
  • Infectious Mononucleosis / drug therapy*
  • Pharyngitis / drug therapy*
  • Pharyngitis / etiology
  • Prospective Studies

Substances

  • Anti-Inflammatory Agents
  • Glucocorticoids
  • Dexamethasone