Recruiting

Fentanyl

Sponsor:

Genesys

Code:

NCT00882960

Conditions

Trauma

Pain

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

intravenous fentanyl

intra-nasal fentanyl

Study Details

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.

Conditions

Trauma

Pain

Study ID

NCT00882960

Start date

Apr, 2009

Status verified date

May, 2009

Completion date

Apr, 2012

Anticipated

Primary completion date

Apr, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

patients who are randomized to receive intravenous fentanyl for control of their pain

active comparator: 2

patients who are randomized to receive intra-nasal fentanyl for control of their pain

Interventions

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.

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 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 ]

Central Contacts and Locations

Central contacts

Ryan P Kirby, M.D.

810-606-5933ryan.kirby@genesys.org

Locations

Genesys Regional Medical Center

Recruiting

Grand Blanc, Michigan, United States, 48439

Contacts

Ryan Kirby, M.D.

810-606-5933ryan.kirby@genesys.org

Principal Investigator:

Ryan P Kirby, M.D.

More Information

Sponsor

Genesys

Last update posted

May 4, 2011

Last verified

May, 2009

Keywords

  • pre-hospital
  • intra-nasal fentanyl
  • patients requiring analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genesys on 2011-05-04.