Ketorolac vs Oxycodone for Great Toe Arthrodesis

Last updated: July 11, 2023
Sponsor: Medstar Health Research Institute
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Ketorolac

Oxycodone

Clinical Study ID

NCT05054868
STUDY00001123
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 - 75 years.
  • Women of childbearing potential must have a negative serum or urine pregnancy testresults within 24 hours before the first dose of ketorolac.
  • Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot proceduresoften performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).

Exclusion

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

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Ketorolac
Phase: 1
Study Start date:
April 14, 2020
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • Amy Loveland

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

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