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| Sponsors and Collaborators: |
Penn State University National Honey Board |
|---|---|
| Information provided by: | Penn State University |
| ClinicalTrials.gov Identifier: | NCT00127686 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents |
| Enrollment: | 105 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17545 | |
| Principal Investigator: | Ian M Paul, MD, MSc | Penn State College of Medicine |
More Information
| Responsible Party: | Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center ( Ian M. Paul, MD, MSc ) |
| Study ID Numbers: | 21163 |
| Study First Received: | August 4, 2005 |
| Last Updated: | November 30, 2007 |
| ClinicalTrials.gov Identifier: | NCT00127686 |
| Health Authority: | United States: Institutional Review Board |
|
cough nocturnal cough upper respiratory tract infection sleep quality |
childhood cough Dextromethorphan Honey |
|
Excitatory Amino Acids Respiration Disorders Cough Naphazoline Signs and Symptoms Oxymetazoline Respiratory Tract Infections |
Respiratory Tract Diseases Phenylephrine Guaifenesin Dextromethorphan Signs and Symptoms, Respiratory Phenylpropanolamine |
|
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Excitatory Amino Acid Agents |
Antitussive Agents Infection Central Nervous System Agents Pharmacologic Actions Excitatory Amino Acid Antagonists |
