TraumaPhase 4NCT00882960
Intranasal Fentanyl for Pain Management
A Phase 4 study testing intravenous fentanyl and intra-nasal fentanyl in people with Trauma and Pain, run by Genesys at 1 site in United States.
Trial summary
Goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved from intravenous Fentanyl. Read more about this study
- Who is it for?
- Ages 14 years and older
- What is being tested?
- intravenous fentanyl and intra-nasal fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons who meet the current State of Michigan County of Oakland and County of Genesee pre-hospital pain requiring analgesia.
- Examples of these patients would be those with fractures, kidney stones, or traumatic injuries, burns.
Who cannot join
- Patients who have compromised nasal pharynx such as those who have obvious fractures or epistaxis.
- Additionally patients who are in the supine position for cervical spine immobilization will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Ryan Kirby, M.D., 810-606-5933, ryan.kirby@genesys.org
Ryan P Kirby, M.D.
About this study
Official title: Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management
Goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.
Read the detailed description
Currently, pre-hospital providers have the ability to administer analgesia to patients through only intravenous routes. Often times patients have been exposed to the elements, present with poor anatomy, or are in such a position that makes establishing intravenous impractical or impossible. The lack of delivery method than prevents the patients from receiving humane and indicated pain medication. In patients who access is achieved, they are first subjected to a painful procedure that often will be repeated within twenty-four hours by most hospital policies and than subjects them to potential infection risk, being often times in less than aseptic conditions.
The goal of the study will be to test the method of administration of pain medication using atomization through an intra-nasal route as compared to the current standard of drug administration intravenous. The medication to be administered will be Fentanyl, a previously established and approved pre-hospital analgesic medication. As with any drug there are potential risks associated with unknown side effects or allergies, the risk would not be enhanced given the use of a different delivery device. Specific risks associated with the use of this delivery route would include but not be limited to potential soft tissue injuries, epistaxis, and aspiration
The study will measure reduction in pain following the delivery of atomized fentanyl via intra-nasal administration as compared with intravenous. We will ask participants to quantify their pain using the Wong-Baker FACES pain scale (previously established valid instrument of pain assessment) and assign a number to the pain they are feeling. The drug will than be administered using the atomizer and two subsequent reports of pain using the same scale will be taken along with vital signs.
- Being tested
- intravenous fentanyl, intra-nasal fentanyl
- Keywords
- pre-hospital, intra-nasal fentanyl, patients requiring analgesia
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous fentanylDrug
An IV will be established and used to deliver Fentanyl at 50 micrograms to patients who meet pre-hospital protocol for pain management. Examples of this may be burn patients, fractures, trauma.
intra-nasal fentanylDrug
a mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients who are randomized to receive intravenous fentanyl for control of their pain Receives: Drug: intravenous fentanyl |
| 2 | Active comparator | patients who are randomized to receive intra-nasal fentanyl for control of their pain Receives: Drug: intra-nasal fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure will be the change recorded in patients subjective pain using a standardized scale
Measured: Pain will be assessed at 5 and 10 minutes post administration of Fentanyl
Secondary outcomes (1)
Change in patients vital signs: blood pressure, respiratory rate, heart rate, pulse oximetry will be monitored at 5 and 10 minutes following Atomized Fentanyl
Measured: 5 and 10 minutes post medication delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genesys
- Sponsor type
- University, hospital or other
- Investigators
- Alan R Janssen, D.O., Study chair, Director of Emergency Medicine Residency, Genesys Regional Medical CenterRyan P Kirby, M.D., Principal investigator, Resident physician, Genesys Regional Medical CenterStuart Etengoff, D.O., Study director, Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882960
- Sponsor's protocol ID
- 104904-1
- Status last verified
- May 2009
- First submitted
- 16 Apr 2009
- Last updated
- 4 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management
- ClinicalTrials.gov ID
- NCT00882960
- Acronym / sponsor ID
- 104904-1
- Keywords
- pre-hospital, intra-nasal fentanyl, patients requiring analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- GenesysUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.
Detailed description
Currently, pre-hospital providers have the ability to administer analgesia to patients through only intravenous routes. Often times patients have been exposed to the elements, present with poor anatomy, or are in such a position that makes establishing intravenous impractical or impossible. The lack of delivery method than prevents the patients from receiving humane and indicated pain medication. In patients who access is achieved, they are first subjected to a painful procedure that often will be repeated within twenty-four hours by most hospital policies and than subjects them to potential infection risk, being often times in less than aseptic conditions.
The goal of the study will be to test the method of administration of pain medication using atomization through an intra-nasal route as compared to the current standard of drug administration intravenous. The medication to be administered will be Fentanyl, a previously established and approved pre-hospital analgesic medication. As with any drug there are potential risks associated with unknown side effects or allergies, the risk would not be enhanced given the use of a different delivery device. Specific risks associated with the use of this delivery route would include but not be limited to potential soft tissue injuries, epistaxis, and aspiration
The study will measure reduction in pain following the delivery of atomized fentanyl via intra-nasal administration as compared with intravenous. We will ask participants to quantify their pain using the Wong-Baker FACES pain scale (previously established valid instrument of pain assessment) and assign a number to the pain they are feeling. The drug will than be administered using the atomizer and two subsequent reports of pain using the same scale will be taken along with vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: intravenous fentanylpatients who are randomized to receive intravenous fentanyl for control of their pain |
| 2 | Active comparator | Drug: intra-nasal fentanylpatients who are randomized to receive intra-nasal fentanyl for control of their pain |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Persons who meet the current State of Michigan County of Oakland and County of Genesee pre-hospital pain requiring analgesia.
- Examples of these patients would be those with fractures, kidney stones, or traumatic injuries, burns.
Key exclusion criteria (2 listed)
- Patients who have compromised nasal pharynx such as those who have obvious fractures or epistaxis.
- Additionally patients who are in the supine position for cervical spine immobilization will be excluded.
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 |
|---|---|---|
| intravenous fentanylAn IV will be established and used to deliver Fentanyl at 50 micrograms to patients who meet pre-hospital protocol for pain management. Examples of this may be burn patients, fractures, trauma. | Drug | 1 |
| intra-nasal fentanyla mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management | Drug | 2 |
Primary outcome
The primary measure will be the change recorded in patients subjective pain using a standardized scale
Time frame: Pain will be assessed at 5 and 10 minutes post administration of Fentanyl
1 secondary outcome
Change in patients vital signs: blood pressure, respiratory rate, heart rate, pulse oximetry will be monitored at 5 and 10 minutes following Atomized Fentanyl
Time frame: 5 and 10 minutes post medication delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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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.
Alan R Janssen, D.O. study chair
Director of Emergency Medicine Residency, Genesys Regional Medical Center
Ryan P Kirby, M.D. principal investigator
Resident physician, Genesys Regional Medical Center
Stuart Etengoff, D.O. study director
Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous fentanyl and intra-nasal fentanyl in people with Trauma and Pain, run by Genesys 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 2 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: status not confirmed, as of the sponsor's last update on 4 May 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan P Kirby, M.D. (810-606-5933, ryan.kirby@genesys.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary measure will be the change recorded in patients subjective pain using a standardized scale (time frame: Pain will be assessed at 5 and 10 minutes post administration of Fentanyl). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2011.