Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Respiratory Tract Diseases

Treatments: Other: Ointment containing camphor, eucalyptus oil, and menthol; Other: Petroleum jelly

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00743990

29273

Details and patient eligibility

About

This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub® (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as rated by both parents and children.

Enrollment: 143 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Cough and congestion attributed to upper respiratory tract infection

Exclusion criteria

• Children with signs or symptoms of more serious or treatable disease
• Presence of itchy, watery eyes or 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
• History of an allergic reaction to camphor, menthol, eucalyptus, petrolatum, cedarleaf oil, nutmeg oil, thymol, turpentine oil, Over-the-counter medication containing VVR components

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Other: Ointment containing camphor, eucalyptus oil, and menthol

B

Placebo Comparator group

Treatment:

Other: Petroleum jelly

3

No Intervention group

Description:

no intervention