Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
Completed · Phase 1
Conditions studied: Cough, Respiratory Tract Infections
In brief
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).
Key facts
- Study ID
- NCT00127686
- Run by
- Penn State University
- People needed
- 105
- Starts
- 2005-09-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2017-11-24
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 2 to <18 years
- Cough due to upper respiratory tract infection (URI), as determined by physical examination
- Sleep difficulty on the preceding night attributed to frequent cough
- Ability to swallow liquids
- Willingness of the child's guardian to participate in a survey
You may not qualify if…
- Signs/symptoms of more serious/treatable disease
- Itchy, watery eyes
- Frequent sneezing, tachypnea (respiratory rate >95th percentile) or labored breathing; symptoms for 8 or more days.
- History of asthma in the past 2 years
- Chronic lung disease, or seizure disorder
- Allergic reaction to honey or DM
- Selective serotonin reuptake inhibitors (SSRIs) or anti-malarial drugs
- Diabetes mellitus or signs/symptoms of insulin resistance
Where it is running
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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