A Randomized Trial of the Effectiveness of Topical "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea
I. Evaluate the use of the gel in the treatment of nausea with a randomized, double blind,
placebo controlled, cross-over clinical trial. The clinically important effect is that the
gel will lead to a two point reduction in the severity of nausea compared to the placebo
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel
topically over 2 minutes and placebo topically over 2 minutes.
ARM II: Patients apply placebo topically over 2 minutes.
After completion of study treatment, patients are followed up for up to 8 hours.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Change in numeric rating scale in self-reported nausea on a 0-10 scale
A reliable and valid instrument for assessing relevant symptoms (on a scale of 0, 1, 2, 3 or 4) including Lack of energy, Lack of appetite, Pain, Dry mouth, Weight loss, Feeling drowsy, Shortness of breath, Constipation, Difficulty sleeping, Difficulty concentrating, and Nausea. Patients' demographics, adverse events, and treatment information, will be listed and summary descriptive statistics will be calculated. A two-sample t-test will be used to compare if the ABH gel is not better than the placebo gel. A repeated measure analysis will be used to compare the two treatment groups.
From baseline to 60 minutes
Virginia Commonwealth University
United States: Institutional Review Board
|Virginia Commonwealth University||Richmond, Virginia|