Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep

NCT00127686 | Completed Phase 1

• 1 other identifier: 21163
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Cough; Respiratory Tract Infections

Keywords

cough; nocturnal cough; upper respiratory tract infection; sleep quality; childhood cough; Dextromethorphan; Honey

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Interventions

Dextromethorphan DRUG

Buckwheat Honey DRUG

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• National Honey Board: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17545, United States

Location

Related Publications (1)

• 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.

  PMID: 18056558 DERIVED

Related Links

• Pediatric Clinical Research Office: Penn State Milton S. Hershey Medical Center

MeSH Terms

Conditions

Cough; Respiratory Tract Infections; Sleep Initiation and Maintenance Disorders

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ian M Paul, MD, MSc

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2005
• First Posted: August 8, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (1)