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Lifeflight: Fentanyl Versus Morphine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by MetroHealth Medical Center.
Recruitment status was:  Recruiting
Cleveland Metro Life Flight
Information provided by:
MetroHealth Medical Center Identifier:
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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 Intervention
Pain Relief Adverse Events Drug: either fentanyl or morphine

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by MetroHealth Medical Center:

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

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

Estimated Enrollment: 200
Study Start Date: August 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Periodic reports are made to the IRB.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00580489

Contact: Michael D Smith, MD 216-778-5747

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
  More Information

Responsible Party: Michael D. Smith, MD, MetroHealth Medical Center, Dept of Emergency Medicine Identifier: NCT00580489     History of Changes
Other Study ID Numbers: Helicopter Fentanyl
Study First Received: December 21, 2007
Last Updated: December 21, 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
Anesthetics processed this record on August 17, 2017