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IVPCA in the Management of Pain Following Major Intracranial Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00286221
First received: February 1, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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 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.


Condition Intervention Phase
Intracranial Surgery
 Drug: IVPCA fentanyl
Drug: PRN fentanyl
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Pain
  • Sedation

Secondary Outcome Measures:
  • Blood pressure
  • Antihypertensive drug administration
  • Opioid administration
  • Nausea/vomiting
  • Pruritus

Estimated Enrollment: 128
Study Start Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults undergoing intracranial surgery

Exclusion Criteria:

Patient refusal

Aphasia Respiratory failure

Allergy/intolerance to fentanyl

Opioids use

Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment

Patient is unable to initiate a bolus dose of IVPCA fentanyl

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286221

Contacts
Contact: Robert D Stevens, MD (410) 955 2611 rstevens@jhmi.edu
Contact: Myron Yaster, MD (410) 955 2393 myaster@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Study Chair: Myron Yaster, MD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00286221     History of Changes
Other Study ID Numbers: 00001283
Study First Received: February 1, 2006
Last Updated: February 1, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013