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Lifeflight: Fentanyl Versus Morphine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00580489
Recruitment Status : Unknown
Verified December 2007 by MetroHealth Medical Center.
Recruitment status was:  Recruiting
First Posted : December 24, 2007
Last Update Posted : December 24, 2007
Cleveland Metro Life Flight
Information provided by:
MetroHealth Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Pain Relief Adverse Events Drug: either fentanyl or morphine

Detailed Description:
Periodic reports are made to the IRB.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting
Study Start Date : August 2006
Estimated Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: C
either fentanyl or morphine
Drug: either fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV
Active Comparator: D
either fentanyl or morphine
Drug: either fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV

Primary Outcome Measures :
  1. Relief of pain by numeric pain scale [ Time Frame: recorded every 5 minutes ]

Secondary Outcome Measures :
  1. Recording of instance of narcotic side effects (vital sign derangement, itching, nausea/vomiting) [ Time Frame: every 5 minutes ]

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580489

Contact: Michael D Smith, MD 216-778-5747 msmith2@metrohealth.org

United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Michael D Smith, MD         
Sponsors and Collaborators
MetroHealth Medical Center
Cleveland Metro Life Flight
Principal Investigator: Michael D Smith, MD MetroHealth Medical Center

Responsible Party: Michael D. Smith, MD, MetroHealth Medical Center, Dept of Emergency Medicine
ClinicalTrials.gov Identifier: NCT00580489     History of Changes
Other Study ID Numbers: Helicopter Fentanyl
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by MetroHealth Medical Center:
pain relief
adverse events

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General