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Completed

NCT Number: NCT00580489

Lifeflight: Fentanyl Versus Morphine

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.

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Key information

Conditions

Pain Relief Adverse Events Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

About this study

Periodic reports are made to the IRB.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

either fentanyl or morphine

Drug

either morphine 4mg IV or fentanyl 50mcg IV

Primary outcomes

  1. Mean Change in Numeric Pain Score (NPS) From First to Last Dose

    Time frame: 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 outcomes

  1. Recording of Instance of Narcotic Side Effects.

    Time frame: 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) .

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 24, 2007
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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