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

NCT04761302 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2025-03-04

Study results available
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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.

Conditions

  • Femur Fracture
  • Tibial Fractures

Interventions

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.

Sponsors & Collaborators

  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Luis F. Lojo-Sojo, MD · Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-18
Primary Completion
2022-10-01
Completion
2022-10-01
FDA Drug
Yes

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04761302 on ClinicalTrials.gov