Effect of Toradol on Post-operative Foot and Ankle Healing

Rothman Institute Orthopaedics

Status and phase: Completed; Phase 4

Conditions: Trauma Injury; Ankle Fractures

Treatments: Other: No ketorolac; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT03727048

2016Raikin

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Other: No ketorolac

Intervention

Experimental group

Description:

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

Treatment:

Drug: Ketorolac