Effect of Toradol on Post-operative Foot and Ankle Healing

Study Overview
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Brief Summary
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The use of Toradol for pain control in surgical orthopedic cases is currently a topic of interest within the field. The proposed study is a prospective randomized study evaluating postoperative pain, opioid requirement, complication/reoperation rates and nonunion rates in patients undergoing surgical treatment for isolated lateral malleolar fibula fractures. Patients will be randomized to either the Treatment Group (Toradol) or the Control Group (Non-Toradol). Both Toradol and non-Toradol drug regimens are currently prescribed by the Foot and Ankle Team at the Rothman Institute and this study will serve as a valuable comparison.

Official Title
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Effect of Toradol on Post-operative Foot and Ankle Healing

Conditions
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Ankle Fractures, Trauma Injury

Intervention / Treatment
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* Drug: Ketorolac
* Other: No ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over age of 18 undergoing outpatient open reduction and internal fixation (ORIF) by a fellowship-trained foot and ankle orthopaedic surgeon for isolated lateral malleolar, bimalleolar, or trimalleolar ankle fractures. Exclusion Criteria: open fracture allergies to one or more of the study medications existing use of narcotics renal insufficiency as defined by history and preoperative creatinine level pregnancy hospital admittance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>To the control group post ankle fracture surgery, per subject 30 tablets of 5/325 oxycodone-acetaminophen with instructions to take 1 or 2 tabs every 4 to 6 hours as needed for pain | Other: No ketorolac<br>* standard of care post operative pain management protocol<br>|
| Experimental: Intervention<br>To the treatment group post ankle fracture surgery, per subject 30mg of IV ketorolac intraoperatively; 20 tablets of 10mg ketorolac with instructions to take every 6 hours, and 30 tablets of 5/325 oxycodone-acetaminophen with instructions to take 1 or 2 tabs every 4 to 6 hours as needed for pain | Drug: Ketorolac<br>* the investigators aimed to evaluate the effect of postoperative ketorolac after ankle fracture surgery on postoperative opioid consumption, pain control, an patient satisfaction.<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score for pain | To evaluate the pain VAS scores of all patients | Days 1-7 post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid pill intake | opioid requirement | Days 1-7 post-op | 
| Radiographic healing | Ankle fracture healing post op via radiographs | 12-33 weeks |