Ketorolac vs Oxycodone for Great Toe Arthrodesis
Purpose
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.
Condition
- Arthrodesis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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)
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Group 1 (Control group) - Oxycodone only |
Subjects randomized to this group will receive oxycodone for postop pain management (standard of care). |
|
|
Experimental Group 2 (Treatment group) - Oxycodone and Ketorolac |
Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute
Detailed Description
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.