BACKGROUND:Young children often appear bothered by ear pain during ascent and descent while traveling on commercial airplanes. While pseudoephedrine hydrochloride is effective in decreasing the risk for earache in adults with recurrent air travel-associated ear pain, such use in children has not been studied. OBJECTIVE: To assess the efficacy and side effects of prophylactic pseudoephedrine in children traveling by air. DESIGN: A placebo-controlled, double-blind clinical trial. SUBJECTS AND METHODS: Children aged 6 months to 6 years were included in this study. Pseudoephedrine hydrochloride (1 mg/kg body weight) or placebo was administered 30 to 60 minutes prior to departure on commercial air flights. Caregivers noted historical details and the degree of apparent ear pain, drowsiness, and excitability with ascent and descent. RESULTS: Ninety-one flights involving 50 children were studied, with ear pain being reported in 13 (14%) of flights. Ear pain was not associated with a history of air travel-associated ear pain, recent ear infection, or recent upper airway symptoms. Pseudoephedrine use was not associated with a decrease in ear pain during either ascent (4% with pseudoephedrine vs 5% with placebo; P approximately 1.00) or descent (12% with pseudoephedrine vs. 13% with placebo; P approximately 1.00). Pseudoephedrine use was, however, linked to drowsiness at takeoff (60% with pseudoephedrine vs. 27% with placebo; P = .003) but not at landing (P = .39). Treatment was not associated with excitability at takeoff (P = .09) or landing (P approximately 1.00). CONCLUSIONS:Ear pain is not uncommon in children traveling by commercial aircraft. The predeparture use of pseudoephedrine does not decrease the risk for in-flight ear pain in children but is associated with drowsiness.
RCT Entities:
BACKGROUND: Young children often appear bothered by ear pain during ascent and descent while traveling on commercial airplanes. While pseudoephedrine hydrochloride is effective in decreasing the risk for earache in adults with recurrent air travel-associated ear pain, such use in children has not been studied. OBJECTIVE: To assess the efficacy and side effects of prophylactic pseudoephedrine in children traveling by air. DESIGN: A placebo-controlled, double-blind clinical trial. SUBJECTS AND METHODS: Children aged 6 months to 6 years were included in this study. Pseudoephedrine hydrochloride (1 mg/kg body weight) or placebo was administered 30 to 60 minutes prior to departure on commercial air flights. Caregivers noted historical details and the degree of apparent ear pain, drowsiness, and excitability with ascent and descent. RESULTS: Ninety-one flights involving 50 children were studied, with ear pain being reported in 13 (14%) of flights. Ear pain was not associated with a history of air travel-associated ear pain, recent ear infection, or recent upper airway symptoms. Pseudoephedrine use was not associated with a decrease in ear pain during either ascent (4% with pseudoephedrine vs 5% with placebo; P approximately 1.00) or descent (12% with pseudoephedrine vs. 13% with placebo; P approximately 1.00). Pseudoephedrine use was, however, linked to drowsiness at takeoff (60% with pseudoephedrine vs. 27% with placebo; P = .003) but not at landing (P = .39). Treatment was not associated with excitability at takeoff (P = .09) or landing (P approximately 1.00). CONCLUSIONS:Ear pain is not uncommon in children traveling by commercial aircraft. The predeparture use of pseudoephedrine does not decrease the risk for in-flight ear pain in children but is associated with drowsiness.