Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures

Phase 4 Completed 167 enrolled University of Puerto Rico

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to determine whether oral acetaminophen and intravenous ketorolac are viable alternatives to opioid medication regimens for the pain management of patients with tibial and femoral shaft fractures treated with intramedullary nailing. This study will explore an alternative for opioid medications for patients undergoing intramedullary nailing of tibial and femoral shaft fractures.

Timeline

Start: 2021-04-18
Primary completion: 2022-10-01
Completion: 2022-10-01

Publications

Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketorolac	Other / unclassified	15 mg	Intravenous
Subject	Ketorolac	Other / unclassified	30 mg	Intravenous
Comparator	Morphine	Other / unclassified	0.1 mg/kg	Intravenous
Comparator	Oxycodone	Other / unclassified	—	Oral
Background	Acetaminophen	Small molecule	1000 mg	Oral

Indications

No indication recorded.