The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period

• Status: Completed
• Trial end date: 2017-01-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem; NorthShore University HealthSystem Research Institute
• Collaborators: Cadence Pharmaceuticals; Mallinckrodt
• Treatments: Acetaminophen

Criteria

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