Lifeflight: Fentanyl Versus Morphine

Not Applicable

Completed

• Conditions: Pain Relief; Adverse Events
• Interventions: Drug: either fentanyl or morphine

• Registration Number: NCT00580489
• Lead Sponsor: MetroHealth Medical Center

Brief 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.

Detailed Description

Periodic reports are made to the IRB.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2017-08-28
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Results First Posted: 2022-08-16
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C Morphine	either fentanyl or morphine	Morphine given to trauma patients transported by helicopter
Arm D Fentanyl	either fentanyl or morphine	Fentanyl given to trauma patients transported by helicopter

Primary Outcome Measures

Name	Time	Method
Mean Change in Numeric Pain Score (NPS) From First to Last Dose	Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.	Mean difference in the numeric pain score (NPS) from the first dose to the final dose of medication administered.; A significant mean pain score change is defined as greater than or equal to 2; Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain

Secondary Outcome Measures

Name	Time	Method
Recording of Instance of Narcotic Side Effects.	Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects.	Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) .

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States