drugset / Trial / NCT00127686

Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep

NCT00127686

Phase 1 Completed 105 enrolled Penn State University National Honey Board · collab
RandomizedFactorialDouble-blindTreatment

Summary

Cough is the most common reason for an acute care doctor's visit in the United States. Cough can affect sleep for both coughing children and their parents. The American Academy of Pediatrics does not endorse the use of dextromethorphan (DM), the most common over-the-counter (OTC) cough medication because of a lack of efficacy data and some potential for toxicity, particularly when taken in excess. In fact, DM has previously been shown to be no better than a placebo for cough in children. Therefore, alternative, therapeutic agents are needed. Honey anecdotally provides relief for symptoms due to upper respiratory tract infection (URI). This study seeks to use a survey to evaluate whether a single dose of honey and/or DM is better than no treatment at all for controlling nocturnal cough in children with URI and the effect of the treatments on sleep quality for coughing children and their parents. A single dose of honey or DM will be superior to no treatment for control of nocturnal cough due to upper URI as rated by both parents and children and will improve the sleep quality for those children and parents. Compared to DM, honey will be superior for controlling nocturnal cough due to upper URI (also based on child and parental report).

Timeline

Start
2005-09
Primary completion
2006-12
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextromethorphan Unknown
Subject buckwheat honey Unknown