Efficacy of PENNSAID® for Pain Management in the Emergency Department

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of PENNSAID® for Pain Management in the Emergency Department

Conditions
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Pain, Ankle Sprain

Intervention / Treatment
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* Drug: PENNSAID
* Drug: Diclofenac hydroxyethylpyrrolidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pennsaid<br>Active Pennsaid and oral placebo | Drug: PENNSAID<br>* 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.<br>|
| Active Comparator: Oral Diclofenac<br>Oral diclofenac and placebo lotion (2.3% DMSO solution) | Drug: Diclofenac hydroxyethylpyrrolidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score | Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac. | Measure at 5 minute intervals for the duration of the ER visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain trajectory model | The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit | nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management