Lifeflight: Fentanyl Versus Morphine
Information source: MetroHealth Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Relief; Adverse Events
Intervention: either fentanyl or morphine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: MetroHealth Medical Center Official(s) and/or principal investigator(s):
Michael D Smith, MD, Principal Investigator, Affiliation: MetroHealth Medical Center
Overall contact:
Michael D Smith, MD, Phone: 216-778-5747, Email: msmith2@metrohealth.org
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.
Clinical Details
Official title: Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Relief of pain by numeric pain scale
Secondary outcome: Recording of instance of narcotic side effects (vital sign derangement, itching, nausea/vomiting)
Detailed description:
Periodic reports are made to the IRB.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Trauma patient
- Able to speak/communicate a pain scale
Exclusion Criteria:
- Age <18
- Age >69
- Initially or any time hypotensive
- Prisoner
Locations and Contacts
Michael D Smith, MD, Phone: 216-778-5747, Email: msmith2@metrohealth.org
MetroHealth Medical Center, Cleveland, Ohio 44109, United States; Recruiting
Michael D Smith, MD, Principal Investigator
Additional Information
Starting date: August 2006
Last updated: December 21, 2007
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