Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2020-04-14
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (Control group) - Oxycodone only
Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).
Oxycodone
Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).
Group 2 (Treatment group) - Oxycodone and Ketorolac
Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
75 Years
ALL
Yes
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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Locations
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Amy Loveland
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00001123
Identifier Type: -
Identifier Source: org_study_id
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