Status:
COMPLETED
IVPCA in the Management of Pain Following Major Intracranial Surgery
Lead Sponsor:
Johns Hopkins University
Conditions:
Intracranial Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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....
Eligibility Criteria
Inclusion
- Adults undergoing intracranial surgery
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00286221
Start Date
March 1 2006
End Date
July 1 2010
Last Update
September 26 2017
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287