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

NCT04136548 | Completed Phase 1 Results FDA Drug

• 1 other identifier: STU 092017-069
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cumulative Stress Index

  Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and fentanyl limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive lower-body negative pressure challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of lower-body negative pressure that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc).

  12 months

Secondary Outcomes (1)

• Pressure Pain Tolerance

  12 months

Study Arms (2)

Fentanyl

EXPERIMENTAL

Fentanyl will be administered intravenously during one visit.

Drug: Fentanyl

Placebo

PLACEBO COMPARATOR

Placebo (saline) will be administered intravenously during one visit.

Other: Placebo

Interventions

Fentanyl DRUG

Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.

Fentanyl

Placebo OTHER

Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Craig Crandall
• Organization: University of Texas Southwestern Medical Center

craigcrandall@texashealth.org

2143454623

Study Officials

• Craig G Crandall, PhD

  Institute for Exercise and Environmental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: June 1, 2019
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)