IVPCA in the Management of Pain Following Major Intracranial Surgery
Completed · Phase 2/Phase 3
Conditions studied: Intracranial Surgery
In brief
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.
Key facts
- Study ID
- NCT00286221
- Run by
- Johns Hopkins University
- People needed
- 159
- Starts
- 2006-03-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2017-09-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults undergoing intracranial surgery
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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