Intranasal Fentanyl for Pain Management
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 14 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2009 |
| End Date: | April 2012 |
| Contact: | Ryan P Kirby, M.D. |
| Email: | ryan.kirby@genesys.org |
| Phone: | 810-606-5933 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
Click here to add this to my saved trials
