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

University of Puerto Rico167 enrolled

Overview

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.

The data analysis for the study will be performed separately for patients with femoral fractures and for patients with tibial fractures. Therefore, the data analysis will compare patients with femoral fractures receiving the experimental treatment to patients with femoral fractures receiving the control treatment (Group 1 vs. Group 2). Likewise, patients with tibial fractures receiving the experimental treatment will be compared to patients with tibial fractures receiving the control treatment (Group 3 vs. Group 4).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

167

Conditions

Femur Fracture Tibial Fractures

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with tibial and femoral shaft fractures 2. Patients undergoing intramedullary nailing 3. Willing to participate in the protocol Exclusion Criteria: 1. Chronic pain disorder (daily use of oral opioids) 2. Allergy or hypersensitivity to non steroid anti-inflammatory drug 3. Impaired renal, cardiac, or hepatic function 4. History of gastrointestinal bleeding or substance abuse

Locations (1)

University District Hospital

San Juan, Puerto Rico

Outcomes

Primary Outcomes

12hrs VAS Pain Scores

Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

Time frame: Measured at postoperative hour 12

24hrs VAS Pain Score

Visual Analog Scale; 0 to 10 (10 indicates highest degree of pain)

Time frame: Measured at postoperative hour 24

36hrs VAS Pain Scores

Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

Time frame: Measured at postoperative hour 36

48hrs VAS Pain Scores

Visual Analog Scale; 0-10 (10 indicates highest degree of pain)

Time frame: Measured at postoperative hour 48

12hrs MME

Opioid consumption at postoperative hour 12. Reported as Morphine Milligram Equivalents (MME)

Time frame: Measured at postoperative hour 12

24hrs MME

Opioid consumption at postoperative hour 24. Reported as Morphine Milligram Equivalents (MME)

Time frame: Measured at postoperative hour 24

36hrs MME

Opioid consumption at postoperative hour 36. Reported as Morphine Milligram Equivalents (MME)

Time frame: Measured at postoperative hour 36

48hrs MME

Opioid consumption at postoperative hour 48. Reported as Morphine Milligram Equivalents (MME)

Time frame: Measured at postoperative hour 48

Secondary Outcomes

Data from ClinicalTrials.gov

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