Adverse Events, Pain Relief
Conditions
Keywords
helicopter, aeromedical, pain relief, analgesia, fentanyl, morphine, adverse events
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.
Interventions
DRUGeither fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Trauma patient * Able to speak/communicate a pain scale
Exclusion criteria
* Age \<18 * Age \>69 * Initially or any time hypotensive * Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Morphine morphine for trauma patients transported by helicopter
either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV | 103 |
| Fentanyl fentanyl for trauma patients transported by helicopter
either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV | 97 |
| Total | 200 |
Baseline characteristics
| Characteristic | Morphine | Fentanyl | Total |
|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 13 | 39 years STANDARD_DEVIATION 13 | 38.5 years STANDARD_DEVIATION 13 |
| Initial Numeric Pain Score | 8.0 units on a scale STANDARD_DEVIATION 2 | 8.0 units on a scale STANDARD_DEVIATION 1.8 | 8.0 units on a scale STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 26 Participants | 23 Participants | 49 Participants |
| Sex: Female, Male Male | 77 Participants | 74 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 103 | 0 / 97 |
| serious Total, serious adverse events | 0 / 103 | 0 / 97 |
Outcome results
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
Time frame: Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.
Population: 4 subjects were excluded from analysis, 1 from the Morphine Group and 3 from the Fentanyl group to achieve the baseline participants for data analysis 103 morphine and 97 fentanyl.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morphine | Mean Change in Numeric Pain Score (NPS) From First to Last Dose | 2.2 score on a scale | Standard Deviation 2 |
| Fentanyl | Mean Change in Numeric Pain Score (NPS) From First to Last Dose | 2.5 score on a scale | Standard Deviation 2.7 |
Secondary
Recording of Instance of Narcotic Side Effects.
Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) .
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.
Population: 4 subjects were excluded from analysis, 1 from the Morphine Group and 3 from the Fentanyl group to achieve the baseline participants for data analysis 103 morphine and 97 fentanyl.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Morphine | Recording of Instance of Narcotic Side Effects. | 0 participants |
| Fentanyl | Recording of Instance of Narcotic Side Effects. | 0 participants |