Trial Outcomes & Findings for Lifeflight: Fentanyl Versus Morphine (NCT NCT00580489)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

204 participants

Primary outcome timeframe

Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.

Results posted on

2022-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Morphine Patients randomized on even days received Morphine 4mg IV	Fentanyl Patients randomized on odd days received Fentanyl 50mcg IV
Overall Study STARTED	104	100
Overall Study COMPLETED	104	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lifeflight: Fentanyl Versus Morphine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine n=103 Participants morphine for trauma patients transported by helicopter either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV	Fentanyl n=97 Participants fentanyl for trauma patients transported by helicopter either fentanyl or morphine: either morphine 4mg IV or fentanyl 50mcg IV	Total n=200 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 13 • n=99 Participants	39 years STANDARD_DEVIATION 13 • n=107 Participants	38.5 years STANDARD_DEVIATION 13 • n=206 Participants
Sex: Female, Male Female	26 Participants n=99 Participants	23 Participants n=107 Participants	49 Participants n=206 Participants
Sex: Female, Male Male	77 Participants n=99 Participants	74 Participants n=107 Participants	151 Participants n=206 Participants
Initial Numeric Pain Score	8.0 units on a scale STANDARD_DEVIATION 2.0 • n=99 Participants	8.0 units on a scale STANDARD_DEVIATION 1.8 • n=107 Participants	8.0 units on a scale STANDARD_DEVIATION 1.9 • n=206 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Morphine n=103 Participants Patients randomized on even days received Morphine 4mg IV	Fentanyl n=97 Participants Patients randomized on odd days received Fentanyl 50mcg IV
Mean Change in Numeric Pain Score (NPS) From First to Last Dose	2.2 score on a scale Standard Deviation 2	2.5 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) .

Outcome measures

Outcome measures
Measure	Morphine n=103 Participants Patients randomized on even days received Morphine 4mg IV	Fentanyl n=97 Participants Patients randomized on odd days received Fentanyl 50mcg IV
Recording of Instance of Narcotic Side Effects.	0 participants	0 participants

Adverse Events

Morphine 4 mg iv

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fentanyl 50mcg IV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charles Emerman

Metrohealth Medical Center

Phone: 2167783577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place