ABSTRACT. Objectives. To determine whether the commonly used over-the-counter medications dextromethorphan and diphenhydramine are superior to placebo for the treatment of nocturnal cough and sleep difficulty associated with upper respiratory infections and to determine whether parents have improved sleep quality when their children receive the medications when compared with placebo.Methods. Parents of 100 children with upper respiratory infections were questioned to assess the frequency, severity, and bothersome nature of the nocturnal cough. Their answers were recorded on 2 consecutive days, initially on the day of presentation, when no medication had been given the previous evening, and then again on the subsequent day, when either medication or placebo was given before bedtime. Sleep quality for both the child and the parent were also assessed for both nights.Results. For the entire cohort, all outcomes were significantly improved on the second night of the study when either medication or placebo was given. However, neither diphenhydramine nor dextromethorphan produced a superior benefit when compared with placebo for any of the outcomes studied. Insomnia was reported more frequently in those who were given dextromethorphan, and drowsiness was reported more commonly in those who were given diphenhydramine.Conclusions. Diphenhydramine and dextromethorphan are not superior to placebo in providing nocturnal symptom relief for children with cough and sleep difficulty as a result of an upper respiratory infection. Furthermore, the medications given to children do not result in improved quality of sleep for their parents when compared with placebo. Each clinician should consider these findings, the potential for adverse effects, and the individual and cumulative costs of the drugs before recommending them to families. Pediatrics 2004;114:e85-e90. URL: http://www.pediatrics.org/cgi/content/full/114/ 1/e85; cough, upper respiratory infection, dextromethorphan, diphenhydramine, placebo.

This study sought to investigate the efficacy of dextromethorphan (DM), diphenhydramine (DPH), and placebo (PL) for symptoms attributed to upper respiratory infections as determined by children, and to evaluate the concordance of perception of nocturnal symptoms between children and parents. A total of 37 children age 6 to 18 years of age were randomized in a double-masked fashion to receive a single bedtime dose of DM, DPH, or PL. Children found no significant difference in the effect of DM, DPH, or PL for any study outcome, and responses by parents and children were significantly correlated.

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Purpose The efficacy of dextromethorphan (DM) for treating cough is uncertain, and its use is not supported by the American Academy of Pediatrics. Still, DM is often given to children as an antitussive. Dosing of DM is based on age, not weight. We sought to determine if a dose‐response relationship existed among a cohort of children given a single nocturnal dose of DM for cough due to an upper respiratory infection. Methods In a double‐masked, placebo‐controlled trial of over‐the‐counter cough medications, 33 children received DM. Dose given was based on the drug label: children 2–5 years ‐ 7.5 mg; children 6–11 years ‐ 15 mg; children 12–18 years ‐ 30 mg. This equated to a range of 0.35–0.94 mg/kg/dose. Subjective parental assessments of cough and sleep were assessed via questions using a 7‐point Likert scale that compared symptoms to the prior night without medication. Three dose ranges were compared. Results (See Table) Conclusion While no statistically significant differences were detectable for the outcomes studied, there was a trend towards improved symptom control with higher doses of DM. This should be considered in future evaluations of the efficacy of DM. Clinical Pharmacology & Therapeutics (2004) 75, P23–P23; doi: Mean Change in Symptom Scores 0.30‐<0.45 mg/kg/dose n=12 0.45‐<0.60 mg/kg/dose n=13 >0.60 mg/kg/dose n=8 p Cough Frequency1.252.382.380.31Cough's Effect on Child's Sleep1.502.002.250.65Cough's Effect on Parent's Sleep1.923.002.380.29Bothersome Nature of Cough1.502.082.250.67Severity of Cough1.332.232.000.54TOTAL7.5011.6911.250.43