IVPCA in the Management of Pain Following Major Intracranial Surgery

This study is not yet open for participant recruitment.

Verified by Johns Hopkins University, January 2006

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00286221

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 II Phase III

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Fentanyl Citrate Fentanyl

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial

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
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

Study Chair:

Myron Yaster, MD

Johns Hopkins University

More Information

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

Study placed in the following topic categories:

Fentanyl
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009