Intranasal Fentanyl for Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882960
Recruitment Status : Unknown
Verified May 2009 by Genesys.
Recruitment status was:  Recruiting
First Posted : April 17, 2009
Last Update Posted : May 4, 2011
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Trauma Pain Drug: intravenous fentanyl Drug: intra-nasal fentanyl Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atomization of Fentanyl: A Randomized Comparison Study of Intranasal Versus Intravenous Fentanyl for Pre-hospital Pain Management
Study Start Date : April 2009
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
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.

Active Comparator: 2
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 5 and 10 minutes post medication delivery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00882960

Contact: Ryan P Kirby, M.D. 810-606-5933

United States, Michigan
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Ryan Kirby, M.D.    810-606-5933   
Principal Investigator: Ryan P Kirby, M.D.         
Sub-Investigator: Stuart Etengoff, D.O.         
Sub-Investigator: Alan R Janssen, D.O.         
Sponsors and Collaborators
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

Responsible Party: Dr. Ryan Kirby, M.D., Genesys Regional Medical Center Identifier: NCT00882960     History of Changes
Other Study ID Numbers: 104904-1
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2009

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

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