Efficacy of PENNSAID® for Pain Management in the Emergency Department
The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy of PENNSAID® for Pain Management in the Emergency Department|
- Change in pain score [ Time Frame: Measure at 5 minute intervals for the duration of the ER visit ] [ Designated as safety issue: No ]Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.
- pain trajectory model [ Time Frame: nine months ] [ Designated as safety issue: No ]The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Pennsaid and oral placebo
active treatment with PENNSAID and oral placebo. Subjects will apply 40 drops of Pennsaid to the affected ankle joint once, and will take a single placebo pill.
Active Comparator: Oral Diclofenac
Oral diclofenac and placebo lotion (2.3% DMSO solution)
Drug: Diclofenac hydroxyethylpyrrolidine
active treatment oral Diclofenac and PENNSAID placebo. Patients will take a single 50mg dose of oral diclofenac and will apply 40 drops of placebo lotion (2.3% DMSO) to the affected ankle once.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350622
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Director:||Richard Chapman, PhD||University of Utah|
|Principal Investigator:||Virgil Davis, MD||University of Utah|