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The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period

NCT01739699 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-11-04

Study results available
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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.

Conditions

  • Craniotomy
  • Brain Surgery

Interventions

DRUG

Acetaminophen

DRUG

Placebo

Sponsors & Collaborators

  • Cadence Pharmaceuticals

    collaborator INDUSTRY

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Steven Greenberg, MD · NorthShore University Health Sytem - Evanston Hospital Department of Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-08-01
Completion
2017-01-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01739699 on ClinicalTrials.gov