Last updated: March 3, 2024
Sponsor: East Carolina University
Overall Status: Completed
Phase
3
Condition
Acute Pain
Sprains
Pain
Treatment
Ibuprofen
Lidocaine Patch 4%
Clinical Study ID
NCT03571737
UMCIRB 17-001594
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject's age is greater than or equal to 18 years old
- Subject is able to speak English
- Subject has chief complaint of musculoskeletal pain lasting less than or equal to 7days
- Subject's area of greatest pain isolated to one body part
- Subject does not have prior Emergency Department visits recorded on electronic medicalrecords for the chief complaint
Exclusion
Exclusion Criteria:
- Subject's age is less than 18 years old
- Subject is pregnant or breastfeeding patients
- Subject cannot speak English
- Subject has multiple traumatic injuries or injury requiring consultation with thetrauma service per study facility's guidelines
- Subject has cellulitis or infection overlying the injuries
- Subject has open wound overlying the injuries
- Subject's chief complaint is caused by penetrating injury
- Subject has absolute contraindications to study medications, including anaphylaxis tolidocaine or nonsteroidal antiinflammatory drugs, history of active GI bleeding orrecent coronary artery bypass graft surgery precluding nonsteroidal antiinflammatorymedications, severe hepatic disease (hepatitis, cirrhosis in current chart or priorhistory or elevation in liver function tests to clinically significant levels in past 6 months), severe kidney disease (Creatinine clearance less than 30 milliliters orhistory of chronic kidney disease stage 3 or worse), congestive heart failure.
- Subject has medication contraindications such as concurrent use of medications listed:Alcuronium, Amphotericin B, Amprenavir, Atracurium, Cimetidine, Edrophonium,Enflurane, Fosphenytoin, Halothane, Nadolol, Oxprenolol, Pentazocine, Propafenone
- Subject is on class I antiarrhythmics therapy (including lidocaine, procainamide,disopyramide etc)
- Subject has injuries requiring splint/casting where patient may not be able to reachthe area of greatest pain to apply and reapply the patch
- Subject has prior history of chronic pain in the affected area (defined as greaterthan or equal to 6 weeks of pain)
- Subject has received opioid medication in triage area or within 4 hours of initialtreatment
- Subject is unable to give pain scores due to mental status
- Subject's initial numerical pain scale score of 0 (which would constitute "no pain" onthe scale)
- Subject requires opiate medication or muscle relaxants (Flexeril, Valium, Tizanidine,Robaxin etc) during the initial visit to Emergency department at the discretion of theprovider.
- Subjects who received less than 800 milligram oral dosage of ibuprofen in triage
Study Design
Total Participants: 23
Treatment Group(s): 2
Primary Treatment: Ibuprofen
Phase: 3
Study Start date:
June 23, 2018
Estimated Completion Date:
January 30, 2021
Study Description
Connect with a study center
Vidant Medical Center
Greenville, North Carolina 27834
United StatesSite Not Available
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