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Safety Study of Analgesia After Craniotomy Surgery With End Tidal CO2 Monitoring

This study has been completed.
Information provided by (Responsible Party):
Athir Morad, Johns Hopkins University Identifier:
First received: March 25, 2011
Last updated: August 29, 2016
Last verified: August 2016
This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, we want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

Condition Intervention Phase
Drug: Fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Craniotomy Analgesia Safety Monitoring With ET CO2

Resource links provided by NLM:

Further study details as provided by Athir Morad, Johns Hopkins University:

Primary Outcome Measures:
  • Respiratory rate < 10 breaths per minute for greater than 2 minutes. [ Time Frame: up to 24 hours ]

Secondary Outcome Measures:
  • oxygen saturation <90%, apnea > 30 secs., ET CO2 > 60, need for narcan, excessive somnolence [ Time Frame: up to 24 hours ]

Enrollment: 137
Study Start Date: May 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PRN fentanyl
A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.
Drug: Fentanyl
25-50 mcg every 20 minutes
Other Name: Non applicable
Active Comparator: IVPCA fentanyl
Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.
Drug: Fentanyl
20mcg/demand dose with an 8 minute lock out
Other Name: Non applicable

Detailed Description:
See brief summary

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study.

Exclusion Criteria:

  • pregnant women
  • patients with post operative neurological changes
  • patients who remain intubated post-operatively
  • patients who require the use of concomitant administration of sedatives

    • patients who are unable to initiate a PCA bolus
    • patients who are unable to communicate verbally
    • patients who are allergic to fentanyl
  • patients who have a history of narcotic abuse
  • patients who have a history of chronic pain requiring opioids
  • patients who have been in any investigational drug trial within 1 month of the treatment day
  • patients who have chronic respiratory insufficiency
  Contacts and Locations
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Please refer to this study by its identifier: NCT01327677

United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Athir H Morad, MD Johns Hopkins University
  More Information

Responsible Party: Athir Morad, Assistant Professor, Johns Hopkins University Identifier: NCT01327677     History of Changes
Other Study ID Numbers: NA_00029336
Study First Received: March 25, 2011
Last Updated: August 29, 2016

Keywords provided by Athir Morad, Johns Hopkins University:
pain management
opioid analgesic therapy

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 May 25, 2017