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Dexamethasone for the Treatment of Sore Throat in Children With Suspected Infectious Mononucleosis
A Randomized, Double-blind, Placebo-Controlled, Clinical Trial
Michel Roy, MD, FRCPC;
Benoit Bailey, MD, MSc, FRCPC;
Devendra K. Amre, MBBS, PhD;
Jean-Bernard Girodias, MD;
Jean-François Bussières, BPharm, MSc, MBA, FCSHP;
Pierre Gaudreault, MD, FRCPC
Arch Pediatr Adolesc Med. 2004;158:250-254.
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.
From the Division of Emergency Medicine (Drs Roy, Bailey, and Girodias), the Division of Clinical Pharmacology and Toxicology (Drs Bailey and Gaudreault), the Department of Pediatrics, Research Centre (Drs Bailey and Amre), and the Department of Pharmacy (Mr Bussières), Hôpital Ste-Justine, Université de Montréal, Montreal, Quebec.
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