Lifeflight: Fentanyl Versus Morphine

Adverse Events Clinical Trial

Official title:

Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580489
• Other study ID #: IRB06-00065
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2022
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Periodic reports are made to the IRB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adverse Events
• Pain Relief

Intervention

Drug:
• either fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL. The effectiveness and adverse events of morphine versus fentanyl on a physician-staffed helicopter. J Emerg Med. 2012 Jul;43(1):69-75. doi: 10.1016/j.jemermed.2011.05.018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Numeric Pain Score (NPS) From First to Last Dose	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	Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.
Secondary	Recording of Instance of Narcotic Side Effects.	Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) .	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.