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IVPCA in the Management of Pain Following Major Intracranial Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286221
First Posted: February 3, 2006
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  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 pro re nata (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: PCA fentanyl Drug: PRN fentanyl Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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:
  • Hourly Pain Scores [ Time Frame: Up to 16 hours ]
    Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)


Secondary Outcome Measures:
  • Fentanyl Consumption [ Time Frame: Up to 16 hours ]
    the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.


Enrollment: 159
Actual Study Start Date: March 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supratentorial PCA fentanyl Drug: PCA fentanyl
PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
Other Name: PCA
Active Comparator: Supratentorial PRN fentanyl Drug: PRN fentanyl
IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Other Name: IV fentanyl
Experimental: Infratentorial PCA fentanyl Drug: PCA fentanyl
PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
Other Name: PCA
Active Comparator: Infratentorial PRN fentanyl Drug: PRN fentanyl
IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))
Other Name: IV fentanyl

  Eligibility

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

Inclusion Criteria:

  • Adults undergoing intracranial surgery

Exclusion Criteria:

  • Patient refusal
  • Pregnancy
  • Aphasia
  • Respiratory failure
  • Allergy/intolerance to fentanyl
  • Opioids use
  • History of opioid-dependent pain,
  • Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
  • Mental or physical limitations that would prevent patient assessment or PCA use
  • Chronic painful conditions unrelated to the reason for surgery,
  • Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
  • Patient is unable to initiate a bolus dose of IVPCA fentanyl
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286221


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Bradford Winters, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00286221     History of Changes
Other Study ID Numbers: NA_00001283
First Submitted: February 1, 2006
First Posted: February 3, 2006
Results First Submitted: July 24, 2017
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017
Last Verified: August 2017

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