Lifeflight: Fentanyl Versus Morphine

MetroHealth Medical Center

Status: Completed

Conditions: Adverse Events; Pain Relief

Treatments: Drug: either fentanyl or morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT00580489

IRB06-00065

Details and patient eligibility

About

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.

Full description

Periodic reports are made to the IRB.

Enrollment: 204 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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204 participants in 2 patient groups

Arm C Morphine

Active Comparator group

Description:

Morphine given to trauma patients transported by helicopter

Treatment:

Drug: either fentanyl or morphine

Arm D Fentanyl

Active Comparator group

Description:

Fentanyl given to trauma patients transported by helicopter

Treatment:

Drug: either fentanyl or morphine