Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 to 80

Participation Criteria

Inclusion Criteria:

1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
2. Patients 18-80 years old inclusive.
3. Patients able to be followed at a METRC facility for at least 12 months following injury

Exclusion Criteria:

1. Patient unable to provide informed consent
2. Patients who are current - intravenous drug user.
3. Patients with a history of allergy to the study drugs.
4. Patients unable to swallow oral medications or without functioning GI tract.
5. Patients with a history of gastrointestinal bleeds or gastric perforation.
6. Patients with a history of stroke or heart attack.
7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
8. Patients with any bleeding disorders.
9. Patients with severe renal failure \[GFR:\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose \[see section 8.6 for defined modified dose\].
10. Patients undergoing daily treatment with systemic glucocorticoids before surgery.
11. 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.
12. Patients with a GCS \<15 at discharge.
13. Patients with a closed head injury that precludes NSAIDS.
14. Patients who are pregnant or lactating at time of screening
15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.