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Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.

Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.

1000mg IV Ofirmev given every six hours for a total of four doses.

IV Acetaminophen

Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.

Saline Placebo

Hugh Hemmings, MD, PhD

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.

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. One group of subjects will receive IV acetaminophen every six hours beginning within 30 minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the other group will receive IV placebo every six hours plus IV morphine PCA, a standard treatment for 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.

Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

A Double-blind, Randomized, Placebo-controlled Study to Compare the Effectiveness of IV Acetaminophen Administered Intra-operatively in Reducing the Use of Opiates to Treat Post-operative Pain

How much morphine the subject consumes in the first 24 hours after surgery (mg).

The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation

2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

Mallinckrodt

Weill Medical College of Cornell University

Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.

Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.

Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.

IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery	NCT01783236	Lung Tumor	IV Acetaminophe... Saline Placebo	18 Years - 99 Years	Weill Medical College of Cornell University
Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery	NCT01783236	Lung Tumor	IV Acetaminophe... Saline Placebo	18 Years - 99 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for ofirmev

Every month we try and update this database with for ofirmev cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ofirmev

Every month we try and update this database with for ofirmev cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ofirmev cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.