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IVPCA in the Management of Pain Following Major Intracranial Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by Johns Hopkins University.
Recruitment status was:  Not yet recruiting
Information provided by:
Johns Hopkins University Identifier:
First received: February 1, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
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
Intervention Model: Single Group Assignment
Masking: None (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:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00286221

Contact: Robert D Stevens, MD (410) 955 2611
Contact: Myron Yaster, MD (410) 955 2393

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00286221     History of Changes
Other Study ID Numbers: 00001283
Study First Received: February 1, 2006
Last Updated: February 1, 2006

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on August 22, 2017