drugset / Trial / NCT01739699

The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period

NCT01739699 ↗

Phase 4 Completed 140 enrolled Endeavor Health Cadence Pharmaceuticals · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-01
Primary completion
2016-08-01
Completion
2017-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Intravenous

Indications

No indication recorded.