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
  Purpose

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).


Condition Intervention Phase
Cough
Respiratory Tract Infections
Drug: Dextromethorphan
Drug: Buckwheat Honey
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 105
Study Start Date: September 2005
Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127686

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17545
Sponsors and Collaborators
Penn State University
National Honey Board
Investigators
Principal Investigator: Ian M Paul, MD, MSc Penn State College of Medicine
  More Information

Additional Information:
No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ian M. Paul, MD, MSc, Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00127686     History of Changes
Other Study ID Numbers: 21163
Study First Received: August 4, 2005
Last Updated: November 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
cough
nocturnal cough
upper respiratory tract infection
sleep quality
childhood cough
Dextromethorphan
Honey

Additional relevant MeSH terms:
Cough
Infection
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dextromethorphan
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014