Lifeflight: Fentanyl Versus Morphine

Study Overview
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Brief Summary
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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
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Periodic reports are made to the IRB.

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

Conditions
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Adverse Events, Pain Relief

Intervention / Treatment
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* Drug: either fentanyl or morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trauma patient Able to speak/communicate a pain scale Exclusion Criteria: Age <18 Age >69 Initially or any time hypotensive Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm C Morphine<br>Morphine given to trauma patients transported by helicopter | Drug: either fentanyl or morphine<br>* either morphine 4mg IV or fentanyl 50mcg IV<br>|
| Active Comparator: Arm D Fentanyl<br>Fentanyl given to trauma patients transported by helicopter | Drug: either fentanyl or morphine<br>* either morphine 4mg IV or fentanyl 50mcg IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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helicopter, aeromedical, pain relief, analgesia, fentanyl, morphine, adverse events