Status:

COMPLETED

Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl

Lead Sponsor:

University of Texas Southwestern Medical Center

Collaborating Sponsors:

United States Department of Defense

Conditions:

Healthy

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

PHASE2

Brief Summary

The purpose of this project is to test how fentanyl, an analgesic currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.

Detailed Description

Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the s...

Eligibility Criteria

Inclusion

  • Healthy
  • Non-obese (body mass index less than 30 kg/m2)
  • Body mass greater than or equal to 65 kg

Exclusion

  • Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
  • Any known history of renal or hepatic insufficiency/disease
  • Pregnancy or breast feeding
  • Current smokers, as well as individuals who regularly smoked within the past 3 years
  • Positive urine drug screen
  • Currently taking pain modifying medication(s)

Key Trial Info

Start Date :

June 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 18 2020

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT04136548

Start Date

June 1 2019

End Date

November 18 2020

Last Update

January 24 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390