Pain ReliefNCT00580489
Lifeflight: Fentanyl Versus Morphine
A study testing either fentanyl or morphine in people with Pain Relief and Adverse Events, run by MetroHealth Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Pain Relief, Adverse Events
- What is being tested?
- either fentanyl or morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma patient
- Able to speak/communicate a pain scale
Who cannot join
- Age <18
- Age >69
- Initially or any time hypotensive
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting
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.
Read the detailed description
Periodic reports are made to the IRB.
- Conditions
- Pain Relief, Adverse Events
- Being tested
- either fentanyl or morphine
- Keywords
- helicopter, aeromedical, pain relief, analgesia, fentanyl, morphine, adverse events
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
either fentanyl or morphineDrug
either morphine 4mg IV or fentanyl 50mcg IV
| Study group | Role | What they receive |
|---|---|---|
| Arm C Morphine | Active comparator | Morphine given to trauma patients transported by helicopter Receives: Drug: either fentanyl or morphine |
| Arm D Fentanyl | Active comparator | Fentanyl given to trauma patients transported by helicopter Receives: Drug: either fentanyl or morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.
Secondary outcomes (1)
Recording of Instance of Narcotic Side Effects.
Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) .
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ReliefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Emerman, MD, MetroHealth Medical Center
- Investigators
- Michael D Smith, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580489
- Sponsor's protocol ID
- IRB06-00065
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2007
- Last updated
- 16 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21689900
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting
- ClinicalTrials.gov ID
- NCT00580489
- Acronym / sponsor ID
- IRB06-00065
- Conditions
- Pain Relief, Adverse Events
- Keywords
- helicopter, aeromedical, pain relief, analgesia, fentanyl, morphine, adverse events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Aug 2006 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Posted 16 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm C Morphine | Active comparator | Drug: either fentanyl or morphineMorphine given to trauma patients transported by helicopter |
| Arm D Fentanyl | Active comparator | Drug: either fentanyl or morphineFentanyl given to trauma patients transported by helicopter |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Trauma patient
- Able to speak/communicate a pain scale
Key exclusion criteria (4 listed)
- Age <18
- Age >69
- Initially or any time hypotensive
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| either fentanyl or morphineeither morphine 4mg IV or fentanyl 50mcg IV | Drug | Arm C Morphine, Arm D Fentanyl |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21689900Smith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Smith, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing either fentanyl or morphine in people with Pain Relief and Adverse Events, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00580489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.