Efficacy of PENNSAID® for Pain Management in the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Utah
- Locations
- 1
- Primary Endpoint
- Change in pain score
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Pennsaid
Active Pennsaid and oral placebo
Intervention: PENNSAID (Drug)
Oral Diclofenac
Oral diclofenac and placebo lotion (2.3% DMSO solution)
Intervention: Diclofenac hydroxyethylpyrrolidine (Drug)
Outcomes
Primary Outcomes
Change in pain score
Time Frame: Measure at 5 minute intervals for the duration of the ER visit
Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.
Secondary Outcomes
- pain trajectory model(nine months)