Recruiting
Phase 1

Ketorolac vs. Oxycodone

Sponsor:

Medstar Health Research Institute

Code:

NCT05054868

Conditions

Arthrodesis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Oxycodone

Ketorolac

Study Details

Brief 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.

Conditions

Arthrodesis

Study ID

NCT05054868

Start date

Apr 14, 2020

Status verified date

Jul, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Oxycodone

Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).

Ketorolac

Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.

Primary outcome measure

  • Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery. [ Time Frame: From baseline to 14 days after the surgery ]
  • Quantitative pain management - measured using a study survey. [ Time Frame: 14 days after the surgery ]

Central Contacts and Locations

Central contacts

Amy Loveland

3015602937amy.loveland@medstar.net

Crisanto Macaraeg

410-261-8218crisanto.l.macaraeg@medstar.net

Locations

Amy Loveland

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Amy Loveland

301-560-2937amy.loveland@medstar.net

Crisanto Macaraeg

4102618218crisanto.l.macaraeg@medstar.net

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Jul 12, 2023

Last verified

Jul, 2023

Keywords

  • big toe arthrodesis
  • big toe
  • joint fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2023-07-12.