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).

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Cough
• Intervention / Treatment: Drug: Dextromethorphan; Drug: Buckwheat Honey

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17545
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Honey Board
• Investigators: Principal Investigator: Ian M Paul, MD, MSc, Penn State College of Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: August 4, 2005
• First Submitted That Met QC Criteria: August 4, 2005
• First Posted (Estimate): August 8, 2005

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: cough; sleep quality; upper respiratory tract infection; Dextromethorphan; Honey; nocturnal cough; childhood cough
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Tract Infections; Cough; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Respiratory System Agents; Antitussive Agents; Dextromethorphan
• Other Study ID Numbers: 21163 (Other Identifier: City of Hope Medical Center)