Effect of Toradol on Post-operative Foot and Ankle Healing

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03727048

Enrollment

128

Registered

2018-11-01

Start date

2016-08-31

Completion date

2018-03-31

Last updated

2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures, Trauma Injury

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.

Interventions

DRUGKetorolac

the investigators aimed to evaluate the effect of postoperative ketorolac after ankle fracture surgery on postoperative opioid consumption, pain control, an patient satisfaction.

OTHERNo ketorolac

standard of care post operative pain management protocol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026