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Craniotomy | The Efficacy of Intravenous Acetaminophen During The Perioperative Period Of Neurosurgical Patients Undergoing Craniotomies

Craniotomy research study

What is the primary objective of this study?

This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned. The following general perioperative data will be recorded: patient information/preoperative data, procedural information, postoperative information, and overall satisfaction of pain management at 24 hours after surgery. Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.

Who is eligible to participate?

Inclusion Criteria: - Subject are able to provide informed consent prior to participation in the study - Subjects must be scheduled to undergo elective open craniotomy procedure of > 2 hour duration - Subjects must be >18 years old but less than 90 years old - Subjects must have an American Society of Anesthesiologists (ASA) class I-IV - Subjects must have the ability to communicate meaningfully with the investigator staff and read/understand the study procedures and the use of pain scales Exclusion Criteria: - Subjects used opioids or tramadol daily for >7 days before study medication administration - Subjects had been treated with any of the following within 14 days of surgery: chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian - Subjects who have a chronic pain condition, significant medical disease or laboratory abnormality that in the investigator's judgment could compromise the subject's welfare - Subjects with known hypersensitivity to opioids, acetaminophen or the inactive ingredients - Subjects with known or suspected history of alcohol or drug abuse or dependence in the previous 2 years prior to the proposed surgery

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Craniotomy

Brain Surgery

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Acetaminophen

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AcetaminophenSubjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.

PlaceboSubjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.

Study Status

Unknown status

Start Date: January 2012

Completed Date: November 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Opioid requirement after surgery

Secondary Outcome: Time to rescue medication in both groups

Study sponsors, principal investigator, and references

Principal Investigator: Steven Greenberg, MD

Lead Sponsor: NorthShore University HealthSystem Research Institute

Collaborator: Mallinckrodt

More information:https://clinicaltrials.gov/show/NCT01739699

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