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The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Intracranial Surgery

Thank you

Trial Information

The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain

Principal Investigator

Myron Yaster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

00001283

NCT ID:

NCT00286221

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Intracranial Surgery

Name

Location

Johns Hopkins HospitalBaltimore, Maryland  21287