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

First Received on December 21, 2007. No Changes Posted

Sponsor:	MetroHealth Medical Center
Collaborator:	Cleveland Metro Life Flight
Information provided by:	MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT00580489

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Fentanyl Fentanyl Citrate

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 February 09, 2012