Efficacy of PENNSAID® for Pain Management in the Emergency Department

Not Applicable

Withdrawn

• Conditions: Pain; Ankle Sprain
• Interventions: Drug: Diclofenac hydroxyethylpyrrolidine; Drug: PENNSAID

• Registration Number: NCT01350622
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Study Start: 2011-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Diclofenac	Diclofenac hydroxyethylpyrrolidine	Oral diclofenac and placebo lotion (2.3% DMSO solution)
Pennsaid	PENNSAID	Active Pennsaid and oral placebo

Primary Outcome Measures

Name	Time	Method
Change in pain score	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 Outcome Measures

Name	Time	Method
pain trajectory model	nine months	The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States