- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03727048
Effect of Toradol on Post-operative Foot and Ankle Healing
October 31, 2018 updated by: Tiffany Morrison, MS, Rothman Institute Orthopaedics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
the investigators aimed to evaluate the effect of postoperative ketorolac after ankle fracture surgery on postoperative opioid consumption, pain control, an patient satisfaction.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog score for pain
Time Frame: Days 1-7 post-op
|
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
Time Frame: Days 1-7 post-op
|
opioid requirement
|
Days 1-7 post-op
|
Radiographic healing
Time Frame: 12-33 weeks
|
Ankle fracture healing post op via radiographs
|
12-33 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Raikin, MD, Rothman Orthopaedic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pradhan BB, Tatsumi RL, Gallina J, Kuhns CA, Wang JC, Dawson EG. Ketorolac and spinal fusion: does the perioperative use of ketorolac really inhibit spinal fusion? Spine (Phila Pa 1976). 2008 Sep 1;33(19):2079-82. doi: 10.1097/BRS.0b013e31818396f4.
- Glassman SD, Rose SM, Dimar JR, Puno RM, Campbell MJ, Johnson JR. The effect of postoperative nonsteroidal anti-inflammatory drug administration on spinal fusion. Spine (Phila Pa 1976). 1998 Apr 1;23(7):834-8. doi: 10.1097/00007632-199804010-00020.
- Cappello T, Nuelle JA, Katsantonis N, Nauer RK, Lauing KL, Jagodzinski JE, Callaci JJ. Ketorolac administration does not delay early fracture healing in a juvenile rat model: a pilot study. J Pediatr Orthop. 2013 Jun;33(4):415-21. doi: 10.1097/BPO.0b013e318288b46f.
- Jeffcoach DR, Sams VG, Lawson CM, Enderson BL, Smith ST, Kline H, Barlow PB, Wylie DR, Krumenacker LA, McMillen JC, Pyda J, Daley BJ; University of Tennessee Medical Center, Department of Surgery. Nonsteroidal anti-inflammatory drugs' impact on nonunion and infection rates in long-bone fractures. J Trauma Acute Care Surg. 2014 Mar;76(3):779-83. doi: 10.1097/TA.0b013e3182aafe0d.
- Reikeraas O, Engebretsen L. Effects of ketoralac tromethamine and indomethacin on primary and secondary bone healing. An experimental study in rats. Arch Orthop Trauma Surg. 1998;118(1-2):50-2. doi: 10.1007/s004020050310.
- Li Q, Zhang Z, Cai Z. High-dose ketorolac affects adult spinal fusion: a meta-analysis of the effect of perioperative nonsteroidal anti-inflammatory drugs on spinal fusion. Spine (Phila Pa 1976). 2011 Apr 1;36(7):E461-8. doi: 10.1097/BRS.0b013e3181dfd163.
- Reuben SS, Ablett D, Kaye R. High dose nonsteroidal anti-inflammatory drugs compromise spinal fusion. Can J Anaesth. 2005 May;52(5):506-12. doi: 10.1007/BF03016531.
- McDonald E, Winters B, Nicholson K, Shakked R, Raikin S, Pedowitz DI, Daniel JN. Effect of Postoperative Ketorolac Administration on Bone Healing in Ankle Fracture Surgery. Foot Ankle Int. 2018 Oct;39(10):1135-1140. doi: 10.1177/1071100718782489. Epub 2018 Jul 4.
- Donohue D, Sanders D, Serrano-Riera R, Jordan C, Gaskins R, Sanders R, Sagi HC. Ketorolac Administered in the Recovery Room for Acute Pain Management Does Not Affect Healing Rates of Femoral and Tibial Fractures. J Orthop Trauma. 2016 Sep;30(9):479-82. doi: 10.1097/BOT.0000000000000620.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
October 30, 2018
First Submitted That Met QC Criteria
October 31, 2018
First Posted (Actual)
November 1, 2018
Study Record Updates
Last Update Posted (Actual)
November 1, 2018
Last Update Submitted That Met QC Criteria
October 31, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Fractures, Bone
- Wounds and Injuries
- Ankle Fractures
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketorolac
- Ketorolac Tromethamine
Other Study ID Numbers
- 2016Raikin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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