Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127686
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2005-08-04
Brief Title:
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cough is the most common reason for an acute care doctors 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 andor 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 doctors 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 doctors 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
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 doctors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None