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Lifeflight: Fentanyl Versus Morphine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by MetroHealth Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cleveland Metro Life Flight
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00580489
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recording of instance of narcotic side effects (vital sign derangement, itching, nausea/vomiting) [ Time Frame: every 5 minutes ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580489

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

Locations
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
Investigators
Principal Investigator: Michael D Smith, MD MetroHealth Medical Center
  More Information

No publications provided

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
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
helicopter
aeromedical
pain relief
analgesia
 fentanyl
morphine
adverse events

Additional relevant MeSH terms:
Fentanyl
Morphine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 18, 2013