Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep



Status:Completed
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:2 - 18
Updated:11/25/2017
Start Date:September 2005
End Date:December 2006

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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).

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.

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
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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mi
from
Hershey, PA
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