NSAIDs for Pain After Ankle Fracture Surgery

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate if it is possible to decrease opioid consumption in patients undergoing ankle fracture surgery by providing scheduled doses of nonsteroidal inflammatory drugs (NSAIDs). This is a prospective, randomized, double-blinded, placebo controlled study with two groups of patients: one getting NSAIDs to take at regularly scheduled times plus a traditional prescription for opioid medication and one receiving the traditional prescription for opioid medication and a placebo. Patients will be assigned to a group from a computer-generated program. Neither the patients nor their doctors or nurses will know what group they are in, only the pharmacist will have that information. Patients in both groups will have the opportunity to take opioid medications if the pain becomes unmanageable.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Naproxen

Criteria

Inclusion Criteria:

1. Age 18 or older

2. Sustained an operative ankle fracture that will be treated at Long Island Jewish Medical Center or North Shore University Hospital

Exclusion Criteria:

1. Open fracture

2. Pregnant women

3. Nursing women

4. Dementia

5. Cognitive compromise requiring legal authorized representative Prisoners

6. Uncontrolled hypertension

7. History of peptic ulcer disease

8. Renal insufficiency

9. History of renal transplant

10. eGFR less than 60 mL/min/1.73 m2

11. Chronic liver disease

12. Blood thinners: vitamin K antagonist, factor Xa inhibitors, heparinoids

13. Chronic steroids

14. Immunosuppressive drugs

15. Inflammatory bowel disease

16. Contraindication/allergy for NSAIDs

17. Positive status for HIV

18. Dixogin

19. Methotrexate

20. Vismodebig