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IVPCA in the Management of Pain Following Major Intracranial Surgery

NCT00286221 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2017-09-26

Study results available
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Summary

This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.

Conditions

  • Intracranial Surgery

Interventions

DRUG

PCA fentanyl

PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted

DRUG

PRN fentanyl

IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))

Sponsors & Collaborators

Principal Investigators

  • Bradford Winters, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00286221 on ClinicalTrials.gov