IVPCA in the Management of Pain Following Major Intracranial Surgery

Johns Hopkins University159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

159

Conditions

Intracranial Surgery

Interventions

PCA fentanylDRUG

PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted

PRN fentanylDRUG

IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Hourly Pain Scores

Patients' Numerical Rating Scale scores (0-10: 0 = no pain, 10 = worst imaginable pain)

Time frame: Up to 16 hours

Secondary Outcomes

Fentanyl Consumption

the amount of fentanyl is that administered in response to corresponding rest pain levels. Thus, the 0 hour indicates the amount of fentanyl administered from the time of admission until the end of the first hour. Also note that once pain assessments are made every other hour (e.g., 10, 12, 14, and 16), the analgesic totals indicated are for the corresponding 2-hour period after the pain assessment, and were halved to estimate the hourly rate of analgesic consumption.

Time frame: Up to 16 hours

Data from ClinicalTrials.gov

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