Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
Condition: Cough; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Cough
Study type: Interventional
Phase: Phase 1

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).
    

Detailed description: 
      Cough is one of the most common reasons for a doctor's visit in the United States and may be
      the most bothersome symptom for children with colds. It is particularly annoying at night
      because it can interrupt sleep for both coughing children and their parents. Dextromethorphan
      (DM), the most common over-the-counter (OTC) "cough medication," may not be as helpful for
      these symptoms as previously believed. Because of this, treatments are needed to better
      reduce the symptoms from a cold. Honey is a naturally occurring substance that may provide
      relief for cold symptoms. Children are being offered the opportunity to take part in this
      research because they have been diagnosed with a cold and have had difficulty sleeping due to
      their cough.

      The purpose of this research is to use a survey to see if a single dose of honey or DM is
      better than no treatment at all for controlling nighttime cough in children, ages 2 to less
      than 18 years with a cold and if the medicine or honey helps the quality of sleep for the
      coughing children and their parents. DM has been approved by the Food and Drug Administration
      (FDA) and is available over the counter. The form of honey used in this study may also be
      purchased without a doctor's prescription.

      About 125 male and female children from 2 to less than 18 years old will take part in this
      study at the Hershey Medical Center.
    

Intervention name(s): Dextromethorphan; Buckwheat Honey
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cough; nocturnal cough; upper respiratory tract infection; sleep quality; childhood cough; Dextromethorphan; Honey