Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep

NCT ID: NCT00127686

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-12-31

Brief 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.

Conditions

Cough; Respiratory Tract Infections

Keywords

cough; nocturnal cough; upper respiratory tract infection; sleep quality; childhood cough; Dextromethorphan; Honey

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Dextromethorphan

Intervention Type: DRUG

Buckwheat Honey

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Honey Board

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian M Paul, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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. doi: 10.1001/archpedi.161.12.1140.

Reference Type: DERIVED

PMID: 18056558 (View on PubMed)

Related Links

http://www.hmc.psu.edu/pedsclinicalresearch/index.htm

Pediatric Clinical Research Office: Penn State Milton S. Hershey Medical Center

Other Identifiers

21163

Identifier Type: -

Identifier Source: org_study_id