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Completed

NCT Number: NCT00286221

IVPCA in the Management of Pain Following Major Intracranial Surgery

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.

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Key information

Conditions

Intracranial Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCA fentanyl

Drug

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

Other names: PCA

PRN fentanyl

Drug

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

Other names: IV fentanyl

Primary outcomes

  1. Hourly Pain Scores

    Time frame: Up to 16 hours

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

Secondary outcomes

  1. Fentanyl Consumption

    Time frame: Up to 16 hours

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

The Safety and Efficacy of IVPCA in the Management of Adult Postoperative Craniotomy Pain: A Prospective, Randomized Controlled Trial

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2006
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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