drugset / Trial / NCT00286221

IVPCA in the Management of Pain Following Major Intracranial Surgery

NCT00286221

Phase 2/3 Completed 159 enrolled Johns Hopkins University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 0.5 ug/kg Intravenous
Subject Fentanyl Other / unclassified 25 ug Intravenous
Subject Fentanyl Other / unclassified 50 ug Intravenous

Indications

No indication recorded.