drugset / Trial / NCT03727048
Effect of Toradol on Post-operative Foot and Ankle Healing
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2016-08
- Primary completion
- 2018-03
- Completion
- 2018-03
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketorolac | Other / unclassified | 10 mg | Intravenous |
Indications
No indication recorded.