To determine the effectiveness of a single dose of oral dexamethasone in reducing the pain associated with moderate to severe pharyngitis in pediatric patients.
Prospective, randomized, double-blind, placebo-controlled clinical trial.
Large, urban pediatric emergency department between March 2002 and November 2003.
Children aged 5 to 18 years with moderate to severe pharyngitis (odynophagia or dysphagia, moderate to severe pharyngeal erythema or swelling, and a McGrath Facial Affective Scale score of 0.75 or higher [scale 0.0-1.0]).
Study patients were randomly assigned to receive 1 dose of either oral dexamethasone suspension (0.6 mg/kg with a maximum of 10 mg) or placebo of the same volume. All participants were tested for group A β-hemolytic streptococcal pharyngitis and treated accordingly. Daily telephone follow-up was conducted until complete resolution of sore throat.
Main Outcome Measures
Primary outcome variables included hours to initial relief of sore throat and time to the complete resolution of pain. Secondary outcome variables included changes in the McGrath Facial Affective Scale score at 24 and 48 hours, persistence of associated symptoms, use of anti-inflammatory or antipyretic medication, and subsequent use of medical resources for dehydration or pain.
A convenience sample of 150 patients was randomized to receive either dexamethasone (n = 75) or placebo (n = 75). Twenty-five patients were lost to follow-up, leaving 125 patients available for data analysis; 57 received dexamethasone and 68 received placebo. Patients who received dexamethasone reported earlier onset of pain relief (9.2 vs 18.2 hours; P<.001), fewer hours to complete resolution of sore throat (30.3 vs 43.8 hours; P = .04), and larger changes in the McGrath Facial Affective Scale score in the first 24 hours (−0.58 vs −0.43; P = .002). Children who tested negative for group A β-hemolytic streptococci had greater pain relief with dexamethasone compared with placebo (onset of pain relief, 8.7 vs 24 hours; P = .001), less time to complete resolution of sore throat (37.9 vs 70.8 hours; P = .006), and greater changes in the McGrath Facial Affective Scale score in the first 24 hours (−0.50 vs −0.21; P<.001).
Children with moderate to severe pharyngitis had earlier onset of pain relief and shorter duration of sore throat when given oral dexamethasone.