Effect of Toradol on Post-operative Foot and Ankle Healing

Phase 4

Completed

• Conditions: Trauma Injury; Ankle Fractures
• Interventions: Drug: Ketorolac; Other: No ketorolac

• Registration Number: NCT03727048
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-10
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-31
• Last Update Submitted: 2018-10-31
• Study First Posted: 2018-11-01
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Ketorolac	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
Control	No ketorolac	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

Primary Outcome Measures

Name	Time	Method
Visual analog score for pain	Days 1-7 post-op	To evaluate the pain VAS scores of all patients

Secondary Outcome Measures

Name	Time	Method
Opioid pill intake	Days 1-7 post-op	opioid requirement
Radiographic healing	12-33 weeks	Ankle fracture healing post op via radiographs