Effect of Toradol on Post-operative Foot and Ankle Healing

Trauma Injury Clinical Trial

Official title:

Effect of Toradol on Post-operative Foot and Ankle Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727048
• Other study ID #: 2016Raikin
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: March 2018

Study information

• Verified date: October 2018
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Trauma Injury

Intervention

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

Other:
• No ketorolac
standard of care post operative pain management protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog score for pain	To evaluate the pain VAS scores of all patients	Days 1-7 post-op
Secondary	Opioid pill intake	opioid requirement	Days 1-7 post-op
Secondary	Radiographic healing	Ankle fracture healing post op via radiographs	12-33 weeks