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Effect of Toradol on Post-operative Foot and Ankle Healing

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ClinicalTrials.gov Identifier: NCT03727048
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Tiffany Morrison, MS, 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.

Condition or disease Intervention/treatment Phase
Ankle Fractures Trauma Injury Drug: Ketorolac Other: No ketorolac Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Toradol on Post-operative Foot and Ankle Healing
Study Start Date : August 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
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
standard of care post operative pain management protocol

Experimental: Intervention
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
the investigators aimed to evaluate the effect of postoperative ketorolac after ankle fracture surgery on postoperative opioid consumption, pain control, an patient satisfaction.
Other Name: Toradol




Primary Outcome Measures :
  1. Visual analog score for pain [ Time Frame: Days 1-7 post-op ]
    To evaluate the pain VAS scores of all patients


Secondary Outcome Measures :
  1. Opioid pill intake [ Time Frame: Days 1-7 post-op ]
    opioid requirement

  2. Radiographic healing [ Time Frame: 12-33 weeks ]
    Ankle fracture healing post op via radiographs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727048


Sponsors and Collaborators
Rothman Institute Orthopaedics
Investigators
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Principal Investigator: Steven Raikin, MD Rothman Orthopaedic

Publications:

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Responsible Party: Tiffany Morrison, MS, Director of Clinical Trials, Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03727048     History of Changes
Other Study ID Numbers: 2016Raikin
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Ankle Fractures
Fractures, Bone
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action