IVPCA in the Management of Pain Following Major Intracranial Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00286221
• Date of registration: 01/02/2006
• Primary sponsor: Johns Hopkins University
• Public title: IVPCA in the Management of Pain Following Major Intracranial Surgery
• Scientific title: The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial
• Date of first enrolment: March 2006
• Target sample size: 128
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00286221
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Robert D Stevens, MD

• Name: Myron Yaster, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Intracranial Surgery

Intervention(s)

Drug: IVPCA fentanyl

Drug: PRN fentanyl

Primary Outcome(s)

Pain

Sedation

Secondary Outcome(s)

Antihypertensive drug administration

Blood pressure

Nausea/vomiting

Opioid administration

Pruritus

Secondary ID(s)

00001283

Source(s) of Monetary Support

Please refer to primary and secondary sponsors