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Intranasal Fentanyl for Pain Management
This study is ongoing, but not recruiting participants.
First Received: April 16, 2009   No Changes Posted
Sponsored by: Genesys
Information provided by: Genesys
ClinicalTrials.gov Identifier: NCT00882960
  Purpose

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.


Condition Intervention Phase
Trauma
Pain
Drug: intravenous fentanyl
Drug: intra-nasal fentanyl
Phase IV

MedlinePlus related topics: Injuries Wounds
Drug Information available for: Fentanyl Fentanyl Citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-Hospital Pain Management

Further study details as provided by Genesys:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
patients who are randomized to receive intravenous fentanyl for control of their pain
Drug: intravenous fentanyl
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.
2: Active Comparator
patients who are randomized to receive intra-nasal fentanyl for control of their pain
Drug: intra-nasal fentanyl
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

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882960

Locations
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys
Investigators
Study Chair: Alan R Janssen, D.O. Director of Emergency Medicine Residency, Genesys Regional Medical Center
Principal Investigator: Ryan P Kirby, M.D. Resident physician, Genesys Regional Medical Center
Study Director: Stuart Etengoff, D.O. Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center
  More Information

No publications provided

Responsible Party: Genesys Regional Medical Center ( Dr. Ryan Kirby, M.D. )
Study ID Numbers: 104904-1
Study First Received: April 16, 2009
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00882960     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Genesys:
pre-hospital
intra-nasal fentanyl
patients requiring analgesia

Study placed in the following topic categories:
Anesthetics, Intravenous
Fentanyl
Anesthetics, General
Adjuvants, Immunologic
Wounds and Injuries
Central Nervous System Depressants
Anesthetics
Narcotics
Pain
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:
Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 06, 2009