Phase 3
N=159
IVPCA in the Management of Pain Following Major Intracranial Surgery
Intracranial Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00286221 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Hourly Pain Scores — 2.5; 3.6; 3.7; 5.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PCA fentanyl (Drug); PRN fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hourly Pain Scores |
2.5; 3.6; 3.7; 5.2 | — |
| SECONDARY Fentanyl Consumption |
44.1; 23.6; 54.8; 29.9 | — |
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.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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00286221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.