CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 167 enrolled
Drug / intervention
Intravenous ketorolac and oral acetaminophen +1 moredrug
Likely dose
Intravenous ketorolac and oral acetaminophen 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04761302
NCT04761302Phase 4Completed

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

University of Puerto Rico·interventional·Posted Feb 18, 2021·Updated Mar 4, 2025

In Brief

A Phase 4 clinical trial evaluating Intravenous ketorolac and oral acetaminophen and Intravenous morphine and oral oxycodone for Femur Fracture and Tibial Fractures. Completed, enrolled 167 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedFeb 18, 2021
Enrollment StartApr 18, 2021
Primary CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.4 years ago

Interventions

Intravenous ketorolac and oral acetaminophendrug

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

Intravenous morphine and oral oxycodonedrug

Morphine 0.1 mg per kg intravenous every 6 hours with an additional oral oxycodone combined with acetaminophen 2 tabs every 6 hours.