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NCT00286221 · ClinicalTrials.gov registry record · Phase 2

IVPCA in the Management of Pain Following Major Intracranial Surgery

A Phase 2 study of Intracranial Surgery, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 2
Development phase
159
Enrollment target
1
Study location

NCT00286221: Completed Phase 2 study of Intracranial Surgery, sponsored by Johns Hopkins University.

NCT00286221 is a Phase 2 study of Intracranial Surgery that has completed, run by Johns Hopkins University. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00286221, a Phase 2 study of Intracranial Surgery, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 2
Development phase
159 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG PCA fentanyl
  • DRUG PRN fentanyl

Study Locations (1)

Maryland

  • Johns Hopkins Hospital - Baltimore

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2006-03
Est. Completion 2010-07
Phase Phase 2
Johns Hopkins University

1,448 total trials

What the finished NCT00286221 record still lists

NCT00286221 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).

The record links to 1 condition, with Intracranial Surgery appearing as the primary indexed condition, and to 2 interventions - of which PCA fentanyl is the first listed.

NCT00286221 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00286221 about?

NCT00286221 is a clinical study titled "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,...

What is the current status of trial NCT00286221?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2006-03. Estimated completion is 2010-07.

What conditions does trial NCT00286221 study?

This clinical trial studies the following conditions: Intracranial Surgery.

What interventions are being tested in trial NCT00286221?

The interventions under investigation include: PCA fentanyl (DRUG), PRN fentanyl (DRUG).

Who is sponsoring clinical trial NCT00286221?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00286221 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00286221's enrollment target sits among peer trials

159 442nd of 2000 higher than 1,558 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00286221, the US trial registry maintained by the National Library of Medicine. NCT00286221 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.