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Trauma | Intranasal Fentanyl for Pain Management

Trauma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Trauma

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:intravenous fentanylAn 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.

Drug:intra-nasal fentanyla mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1patients who are randomized to receive intravenous fentanyl for control of their pain

2patients who are randomized to receive intra-nasal fentanyl for control of their pain

Study Status

Unknown status

Start Date: April 2009

Completed Date: April 2012

Phase: Phase 4

Type: Interventional

Design:

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

Study sponsors, principal investigator, and references

Principal Investigator: Alan R Janssen, D.O.

Lead Sponsor: Genesys

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00882960

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