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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

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

ArmDescriptionAssigned Intervention
Active Comparator
Group 1 (Control group) - Oxycodone only 		Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).
  • Drug: Oxycodone
    Subjects randomized to the control 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.
  • Drug: Oxycodone
    Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).
  • Drug: Ketorolac
    Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.

Recruiting Locations

Amy Loveland
Baltimore, Maryland 21218
Contact:
Amy Loveland
301-560-2937
amy.loveland@medstar.net

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Amy Loveland
3015602937
amy.loveland@medstar.net

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.