Efficacy of PENNSAID® for Pain Management in the Emergency Department

Utah System of Higher Education (USHE)

Status: Withdrawn

Conditions: Ankle Sprain; Pain

Treatments: Drug: PENNSAID; Drug: Diclofenac hydroxyethylpyrrolidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01350622

49065

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

-We will include ED patients presenting with an acutely painful ankle sprain for which NSAIDs constitute standard of care pain management.

The following will be excluded:

• Those with lacerations, bites, burns
• any head trauma
• pregnant
• anyone with a pre-existing chronic pain condition
• inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis
• anyone regularly using another NSAID or anti-coagulation medication
• anyone who has experienced asthma after NSAID use
• compromised cognitive abilities
• a significant co-morbidity that will compromise participation
• had joint replacements
• known hypersensitivity to diclofenac or allergic responses to NSAIDs as a class
• active stomach and/or duodenal ulceration or gastrointestinal bleeding
• anyone admitted with severe active bleeding
• recent heart surgery
• severe liver or renal insufficiency
• prisoner
• mentally disabled patients
• wards of the state
• cognitive or decisional impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Pennsaid

Experimental group

Description:

Active Pennsaid and oral placebo

Treatment:

Drug: PENNSAID

Oral Diclofenac

Active Comparator group

Description:

Oral diclofenac and placebo lotion (2.3% DMSO solution)

Treatment:

Drug: Diclofenac hydroxyethylpyrrolidine