drugset / Trial / NCT04761302

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

NCT04761302 ↗

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

Outcome

Mixed primary results

paper A significant decrease in VAS scores was observed at the 24-hour interval in the NSAID group compared with the opioid group ( P -value 0.041). PMID 38579315 ↗

paper No significant change in visual analog scale scores was observed at 12, 36, and 48 hours between both groups PMID 38579315 ↗

paper A statistically significant decrease in MMEs was noted at every measured interval (12, 24, 36, and 48 hours) PMID 38579315 ↗

registry analysis (superiority test); Group 3: Femoral Fracture Patients Receiving Intravenous Ketorolac and Oral Acetaminophen vs Group 4: Femoral Fracture Patients Receiving Intravenous Morphine and Oral Oxycodone; p = 0.300 NCT04761302 ↗

Drugs

EvaluationDrugModalityDoseRoute
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.