IVPCA in the Management of Pain Following Major Intracranial Surgery
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2017 |
| Start Date: | March 2006 |
| End Date: | July 2010 |
The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial
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.
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.
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
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