Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Detailed Description
-----------------
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Official Title
-----------------
Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Acetaminophen or Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-90 years old undergoing non-emergent craniotomy or single level lumbar laminectomy must be able to rate pain on a 0-10 scale post-operatively Exclusion Criteria: history of liver disease allergy to acetaminophen age less than 18 years renal failure with creatinine clearance less than 30 pregnancy altered mentation with inability to report pain score patients who have received acetaminophen within 6 hours of surgery patients in which a neuraxial technique has been performed for surgery prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen & Craniotomy<br>Drug: Acetaminophen 1000mg administered intravenously during craniotomy | Drug: Acetaminophen or Placebo<br>* Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for No acetaminophen for 6 hours post operatively.<br>|
| Placebo Comparator: Placebo & Craniotomy<br>Placebo administered intravenously during craniotomy. | Drug: Acetaminophen or Placebo<br>* Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for No acetaminophen for 6 hours post operatively.<br>|
| Experimental: Acetaminophen & Laminectomy<br>Acetaminophen 1000mg administered intravenously during laminectomy. | Drug: Acetaminophen or Placebo<br>* Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for No acetaminophen for 6 hours post operatively.<br>|
| Placebo Comparator: Placebo & Laminectomy<br>Placebo administered during laminectomy. | Drug: Acetaminophen or Placebo<br>* Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for No acetaminophen for 6 hours post operatively.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours). | 1hour -6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid administration | Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups. | 1 hour-6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acetaminophen, pain, laminectomy, craniotomy