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Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep

Primary Purpose

Cough, Respiratory Tract Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Buckwheat Honey
Sponsored by
Penn State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring cough, nocturnal cough, upper respiratory tract infection, sleep quality, childhood cough, Dextromethorphan, Honey

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 4, 2005
Last Updated
November 21, 2017
Sponsor
Penn State University
Collaborators
National Honey Board
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1. Study Identification

Unique Protocol Identification Number
NCT00127686
Brief Title
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
Official Title
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
National Honey Board

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Respiratory Tract Infections
Keywords
cough, nocturnal cough, upper respiratory tract infection, sleep quality, childhood cough, Dextromethorphan, Honey

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Type
Drug
Intervention Name(s)
Buckwheat Honey
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian M Paul, MD, MSc
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17545
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18056558
Citation
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.
Results Reference
derived
Links:
URL
http://www.hmc.psu.edu/pedsclinicalresearch/index.htm
Description
Pediatric Clinical Research Office: Penn State Milton S. Hershey Medical Center

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Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep

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