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Completed

NCT Number: NCT03727048

Effect of Toradol on Post-operative Foot and Ankle Healing

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.

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Key information

Conditions

Ankle Fractures Accidental Injuries Ankle Injuries Fractures, Bone Leg Injuries Trauma Injury Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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: Toradol

No ketorolac

Other

standard of care post operative pain management protocol

Primary outcomes

  1. Visual analog score for pain

    Time frame: Days 1-7 post-op

    To evaluate the pain VAS scores of all patients

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2018
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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