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 are 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 control nocturnal cough due to upper URI, also based on child and parental report.

Condition	Intervention	Phase
Cough Respiratory Tract Infection	Drug: Dextromethorphan  Drug: Buckwheat Honey	Phase I

Further Study Details: 

Primary Outcomes: 1) Compared with no treatment, honey and DM will:; a) Improve the sleep quality for children with cough due to URI.; b) Improve the sleep quality for the parents of children with cough due to URI.; 2) Compared to DM, honey will:; a) Improve the sleep quality for children with cough due to URI.; b) Improve the sleep quality for the parents of children with cough due to URI.
Expected Total Enrollment:  125

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. Your child is being offered the opportunity to take part in this research because he/she has been diagnosed with a cold and has 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 are 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.

Ages Eligible for Study:  2 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age 2- <18 years
• Cough due to upper respiratory tract infection (URI) 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 >95%ile) 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00127686

Jessica SB Beiler, MPH      717-531-1260    jbeiler@psu.edu

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

Study chairs or principal investigators

Ian M Paul, MD, MSc,  Principal Investigator,  Penn State College of Medicine   

Study ID Numbers:  21163
Last Updated:  August 5, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00127686
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23