drugset / Trial / NCT01783236

Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

NCT01783236 ↗

RandomizedParallel-groupTriple-blindPrevention

Summary

We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.

Timeline

Start
2013-06
Primary completion
2015-02
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1000 mg Intravenous

Indications