NCT01327677

Brief Summary

This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started May 2011

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

May 31, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

March 25, 2011

Results QC Date

March 9, 2017

Last Update Submit

May 2, 2017

Conditions

Pain

Keywords

pain managementopioid analgesic therapysafetycraniotomy

Outcome Measures

Primary Outcomes (2)

  • Respiratory Depression

    Defined by minimum respiratory rate (breaths/minute).

    up to 24 hours postoperatively

  • Respiratory Depression

    Defined by maximal End Tidal CO2 (mmHg)

    Up to 24 hours postoperatively.

Secondary Outcomes (1)

  • Hypoxia

    up to 24 hours postoperatively

Other Outcomes (1)

  • Mean Fentanyl Consumption

    up to 24 hours postoperatively

Study Arms (2)

Pro re nata (PRN) fentanyl

ACTIVE COMPARATOR

A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.

Drug: Fentanyl

Intravenous Patient-controlled Analgesia (IVPCA) fentanyl

ACTIVE COMPARATOR

Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.

Drug: Fentanyl

Interventions

FentanylDRUG

25-50 mcg every 20 minutes

Also known as: Fentanyl PRN
Pro re nata (PRN) fentanyl

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study.

You may not qualify if:

  • pregnant women
  • patients with post operative neurological changes
  • patients who remain intubated post-operatively
  • patients who require the use of concomitant administration of sedatives
  • patients who are unable to initiate a PCA bolus
  • patients who are unable to communicate verbally
  • patients who are allergic to fentanyl
  • patients who have a history of narcotic abuse
  • patients who have a history of chronic pain requiring opioids
  • patients who have been in any investigational drug trial within 1 month of the treatment day
  • patients who have chronic respiratory insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Athir Morad, M.D.
Organization
Johns Hopkins University School of Medicine
morada@jhmi.edu
4109552611

Study Officials

  • Athir H Morad, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2011

First Posted

April 1, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 31, 2017

Results First Posted

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)