Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
III
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Research_Recruitment@jh.eduBrief Summary
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).
Eligibility
Inclusion Criteria:
- All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
- Patients 18-80 years old inclusive.
- Patients able to be followed at a Major Extremity Trauma & Rehabilitation (METRC) facility for at least 12 months following injury
Exclusion Criteria:
- Patient unable to provide informed consent
- Patients who are current - intravenous drug user.
- Patients with a history of allergy to the study drugs.
- Patients unable to swallow oral medications or without functioning GI tract.
- Patients with a history of gastrointestinal bleeds or gastric perforation.
- Patients with a history of stroke or heart attack.
- Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
- Patients with any bleeding disorders.
- Patients with severe renal failure [glomerular filtration rate (GFR):<30]. Patients with moderate renal failure [GFR: 30-59] may participate in the study at a modified dose.
- Patients undergoing daily treatment with systemic glucocorticoids before surgery.
- Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
- Patients with a Glasgow Coma Scale (GCS) <15 at discharge.
- Patients with a closed head injury that precludes NSAIDS.
- Patients who are pregnant or lactating at time of screening
- Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.