Intranasal Fentanyl for Pain Management
Information source: Genesys
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Trauma; Pain
Intervention: intravenous fentanyl (Drug); intra-nasal fentanyl (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Genesys Official(s) and/or principal investigator(s): Alan R Janssen, D.O., Study Chair, Affiliation: Director of Emergency Medicine Residency, Genesys Regional Medical Center Ryan P Kirby, M.D., Principal Investigator, Affiliation: Resident physician, Genesys Regional Medical Center Stuart Etengoff, D.O., Study Director, Affiliation: Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center
Overall contact: Ryan P Kirby, M.D., Phone: 810-606-5933, Email: ryan.kirby@genesys.org
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. It is hypothesized that pain should be reduced following
fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.
Clinical Details
Official title: Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary measure will be the change recorded in patients subjective pain using a standardized scale
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
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.
Eligibility
Minimum age: 14 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Ryan P Kirby, M.D., Phone: 810-606-5933, Email: ryan.kirby@genesys.org
Genesys Regional Medical Center, Grand Blanc, Michigan 48439, United States; Recruiting Ryan Kirby, M.D., Phone: 810-606-5933, Email: ryan.kirby@genesys.org Ryan P Kirby, M.D., Principal Investigator Stuart Etengoff, D.O., Sub-Investigator Alan R Janssen, D.O., Sub-Investigator
Additional Information
Starting date: April 2009
Last updated: May 3, 2011
|