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Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep

This study has been completed.
Sponsor:
Collaborator:
National Honey Board
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00127686
First received: August 4, 2005
Last updated: November 30, 2007
Last verified: November 2007

August 4, 2005
November 30, 2007
September 2005
Not Provided
Compared with no treatment, honey and DM will: improve the sleep quality for children with cough due to URI and improve the sleep quality for the parents of children with cough due to URI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • a) Improve the sleep quality for children with cough due to URI.
  • b) Improve the sleep quality for the parents of children with cough due to URI.
  • 1) Compared with no treatment, honey and DM will:
  • 2) Compared to DM, honey will:
Complete list of historical versions of study NCT00127686 on ClinicalTrials.gov Archive Site
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Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents

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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cough
  • Respiratory Tract Infections
  • Drug: Dextromethorphan
  • Drug: Buckwheat Honey
Not Provided
Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2006
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00127686
21163
Not Provided
Ian M. Paul, MD, MSc, Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center
Penn State University
National Honey Board
Principal Investigator: Ian M Paul, MD, MSc Penn State College of Medicine
Penn State University
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP