CompletedPhase 4

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

Puerto Rico167 participantsStarted 2021-04-18

Plain-language 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.

Who can participate

Age range18 Years – 110 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

12hrs VAS Pain Scores

Timeframe: Measured at postoperative hour 12

24hrs VAS Pain Score

Timeframe: Measured at postoperative hour 24

36hrs VAS Pain Scores

Timeframe: Measured at postoperative hour 36

48hrs VAS Pain Scores

Timeframe: Measured at postoperative hour 48

12hrs MME

Timeframe: Measured at postoperative hour 12

24hrs MME

Timeframe: Measured at postoperative hour 24

36hrs MME

Timeframe: Measured at postoperative hour 36

48hrs MME

Timeframe: Measured at postoperative hour 48

Trial details

NCT IDNCT04761302

SponsorUniversity of Puerto Rico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-01

Results submitted2023-09-13

View on ClinicalTrials.gov More Femur Fracture trials