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Nonsteroidal Anti-inflammatory Drug

Ketorolac vs Oxycodone for Post-Surgical Pain After Great Toe Joint Fusion

Phase 1
Recruiting
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 75 years
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days after the surgery
Awards & highlights

Study Summary

This trial looks at whether ketorolac can help manage pain and improve healing after joint fusion surgery.

Who is the study for?
This trial is for adults aged 18-75 undergoing elective great toe joint fusion surgery, without severe kidney disease, gastric ulcers, chronic pain syndromes like CRPS or fibromyalgia, tobacco use, diabetes, drug abuse issues. They must not be pregnant or breastfeeding and should be able to understand English.Check my eligibility
What is being tested?
The study compares the effectiveness of ketorolac versus oxycodone in managing post-surgical pain after a toe joint fusion procedure. It also examines whether ketorolac impacts bone healing following the surgery.See study design
What are the potential side effects?
Ketorolac may cause stomach upset, bleeding risks, and potential kidney problems. Oxycodone can lead to nausea, constipation, drowsiness and has a risk for dependency or abuse.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am scheduled for a big toe joint fusion surgery, possibly with other toe surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 14 days after the surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 14 days after the surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery.
Quantitative pain management - measured using a study survey.
Secondary outcome measures
Bone fusion
Other outcome measures
Bone fusion - doctor will review the 3 month postop x-ray to see if the bones have fused at the site of surgery

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 (Treatment group) - Oxycodone and KetorolacExperimental Treatment2 Interventions
Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.
Group II: Group 1 (Control group) - Oxycodone onlyActive Control1 Intervention
Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxycodone
2014
Completed Phase 4
~2210
Ketorolac
2014
Completed Phase 4
~1760

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
191 Previous Clinical Trials
117,578 Total Patients Enrolled

Media Library

Ketorolac (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05054868 — Phase 1
Joint Fusion Research Study Groups: Group 1 (Control group) - Oxycodone only, Group 2 (Treatment group) - Oxycodone and Ketorolac
Joint Fusion Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT05054868 — Phase 1
Ketorolac (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05054868 — Phase 1
~1 spots leftby Jul 2024
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