Effect of Toradol on Post-operative Foot and Ankle Healing

NCT03727048 | Completed Phase 4 FDA Drug

• 1 other identifier: 2016Raikin
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Fractures; Trauma Injury

Outcome Measures

Primary Outcomes (1)

• Visual analog score for pain

  To evaluate the pain VAS scores of all patients

  Days 1-7 post-op

Secondary Outcomes (2)

• Opioid pill intake

  Days 1-7 post-op

• Radiographic healing

  12-33 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: No ketorolac

Intervention

EXPERIMENTAL

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

Drug: Ketorolac

Interventions

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.

Also known as: Toradol

Intervention

No ketorolac OTHER

standard of care post operative pain management protocol

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Related Publications (9)

• 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.

  PMID: 23653032 BACKGROUND

• 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.

  PMID: 24553548 BACKGROUND

• 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.

  PMID: 9833106 BACKGROUND

• 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.

  PMID: 9563116 BACKGROUND

• 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.

  PMID: 20489674 BACKGROUND

• 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.

  PMID: 15872130 BACKGROUND

• 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.

  PMID: 18698276 BACKGROUND

• 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.

  PMID: 29972028 BACKGROUND

• 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.

  PMID: 27124828 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Accidental Injuries

Interventions

Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Steven Raikin, MD

  Rothman Orthopaedic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: August 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share