Ketorolac vs Oxycodone for Great Toe Arthrodesis

• Status: Recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medstar Health Research Institute
• Treatments: Ketorolac; Oxycodone

Criteria

Inclusion Criteria:

• Age 18 - 75 years.

• Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.

• Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).

Exclusion Criteria:

• Chronic pain syndrome, CRPS or fibromyalgia

• Revision procedures

• Use of allograft bone at the fusion site

• Tobacco use

• Diabetes

• Narcotic abuse or IV drug abuse

• Any CPT codes involving the midfoot, hindfoot, and/or ankle

• Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers

• Weight < 50 kg

• Does not speak or read English

• If pregnant or planning to become pregnant or breastfeeding

• Non-independent dweller (prisoner)