Clinical trial NCT03727048: Effect of Toradol on Post-operative Foot and Ankle Healing
Official title: Effect of Toradol on Post-operative Foot and Ankle Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Fractures
Trauma Injury
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Visual analog score for pain
timeFrame: Days 1-7 post-op
Secondary outcomes:
measure: Opioid pill intake
timeFrame: Days 1-7 post-op
measure: Radiographic healing
timeFrame: 12-33 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Rothman Orthopaedic
name: Steven Raikin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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