NCT04761302

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: University of Puerto Rico · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Accepted

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.

Detailed description

The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).

Conditions

• Femur Fracture
• Tibial Fractures

Interventions

Type	Name	Description
DRUG	Intravenous ketorolac and oral acetaminophen	ketorolac 30 mg intravenous (IV) every 6 hours for patients younger than 70 years versus ketorolac 15 mg IV every 6 hours for patients older than 70 years, first dose will be administered 30 minutes preoperatively. An additional 1000mg of oral acetaminophen will be administered every 6 hours simultaneously regardless of the age group
DRUG	Intravenous morphine and oral oxycodone	Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.

Timeline

• Start date: 2021-04-18
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2021-02-18
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

1 site across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study