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Effect of Toradol on Post-operative Foot and Ankle Healing

Primary Purpose

Ankle Fractures, Trauma Injury

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketorolac
No ketorolac
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Visual analog score for pain
    To evaluate the pain VAS scores of all patients

    Secondary Outcome Measures

    Opioid pill intake
    opioid requirement
    Radiographic healing
    Ankle fracture healing post op via radiographs

    Full Information

    First Posted
    October 30, 2018
    Last Updated
    October 31, 2018
    Sponsor
    Rothman Institute Orthopaedics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03727048
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    March 2018 (Actual)
    Study Completion Date
    March 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rothman Institute Orthopaedics

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Fractures, Trauma Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac
    Other Intervention Name(s)
    Toradol
    Intervention Description
    the investigators aimed to evaluate the effect of postoperative ketorolac after ankle fracture surgery on postoperative opioid consumption, pain control, an patient satisfaction.
    Intervention Type
    Other
    Intervention Name(s)
    No ketorolac
    Intervention Description
    standard of care post operative pain management protocol
    Primary Outcome Measure Information:
    Title
    Visual analog score for pain
    Description
    To evaluate the pain VAS scores of all patients
    Time Frame
    Days 1-7 post-op
    Secondary Outcome Measure Information:
    Title
    Opioid pill intake
    Description
    opioid requirement
    Time Frame
    Days 1-7 post-op
    Title
    Radiographic healing
    Description
    Ankle fracture healing post op via radiographs
    Time Frame
    12-33 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steven Raikin, MD
    Organizational Affiliation
    Rothman Orthopaedic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23653032
    Citation
    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.
    Results Reference
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    PubMed Identifier
    24553548
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9833106
    Citation
    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.
    Results Reference
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    PubMed Identifier
    9563116
    Citation
    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.
    Results Reference
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    PubMed Identifier
    20489674
    Citation
    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.
    Results Reference
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    PubMed Identifier
    15872130
    Citation
    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.
    Results Reference
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    PubMed Identifier
    18698276
    Citation
    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.
    Results Reference
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    PubMed Identifier
    29972028
    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.
    Results Reference
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    PubMed Identifier
    27124828
    Citation
    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.
    Results Reference
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    Effect of Toradol on Post-operative Foot and Ankle Healing

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