Lifeflight: Fentanyl Versus Morphine

July 18, 2022 updated by: Charles Emerman, MD, MetroHealth Medical Center

Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting

The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Periodic reports are made to the IRB.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Trauma patient
  • Able to speak/communicate a pain scale

Exclusion Criteria:

  • Age <18
  • Age >69
  • Initially or any time hypotensive
  • Prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm C Morphine
Morphine given to trauma patients transported by helicopter
Drug: either fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV
Active Comparator: Arm D Fentanyl
Fentanyl given to trauma patients transported by helicopter
Drug: either fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Numeric Pain Score (NPS) From First to Last Dose
Time Frame: Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.

Mean difference in the numeric pain score (NPS) from the first dose to the final dose of medication administered.

A significant mean pain score change is defined as greater than or equal to 2

Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain
Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording of Instance of Narcotic Side Effects.
Time Frame: Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects.
Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) .
Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Investigators

  • Principal Investigator: Michael D Smith, MD, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 24, 2007

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB06-00065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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