Pain, Ankle Sprain
Conditions
Keywords
pain management
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.
Interventions
DRUGPENNSAID
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 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.
Sponsors
Medtronic - MITG
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed