Phase 4
N=167
Postoperative Pain Management in Patients Undergoing Intramedullary Nail Fixation After Tibia and Femoral Fractures
Femur Fracture · Tibial Fractures
Bottom Line
View on ClinicalTrials.gov: NCT04761302 ↗Enrolled (actual)
167
Serious AEs
11.8%
Results posted
Mar 2025
Primary outcome: Primary: 12hrs VAS Pain Scores — 7.6; 7.9; 7.3; 7.2 score on a scale — p=0.215
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intravenous ketorolac and oral acetaminophen (Drug); Intravenous morphine and oral oxycodone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Puerto Rico
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12hrs VAS Pain Scores |
7.6; 7.9; 7.3; 7.2 | 0.215 |
| PRIMARY 24hrs VAS Pain Score |
4.9; 5.9; 5.4; 5.1 | 0.041 sig |
| PRIMARY 36hrs VAS Pain Scores |
4.9; 5.63; 5.3; 5.6 | 0.12 |
| PRIMARY 48hrs VAS Pain Scores |
3.6; 4.3; 4.0; 3.4 | 0.083 |
| PRIMARY 12hrs MME |
2.9; 8.5; 2.9; 12.1 | 0.002 sig |
| PRIMARY 24hrs MME |
9.2; 21.49; 10.4; 28.8 | 0.002 sig |
| PRIMARY 36hrs MME |
14.1; 29.5; 15.7; 36.6 | 0.004 sig |
| PRIMARY 48hrs MME |
18.3; 37.2; 20.1; 48.0 | 0.006 sig |
| SECONDARY Hospital Length of Stay |
1.9; 2.00; 1.8; 1.9 | 0.354 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with tibial and femoral shaft fractures
- Patients undergoing intramedullary nailing
- Willing to participate in the protocol
Exclusion Criteria
- Chronic pain disorder (daily use of oral opioids)
- Allergy or hypersensitivity to non steroid anti-inflammatory drug
- Impaired renal, cardiac, or hepatic function
- History of gastrointestinal bleeding or substance abuse
Data sourced from ClinicalTrials.gov (NCT04761302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.