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

NCT ID: NCT04959812

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-09-08

Brief Summary

This study will examine how sufentanil (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in the research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.

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 selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.

This study will test the hypothesis that sufentanil will impair the capacity for a conscious human to tolerate a hemorrhagic insult.

The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sufentanil

Sufentanil (30 microgram tablet) will be administered via a sublingual pill

Group Type: EXPERIMENTAL

Sufentanil

Intervention Type: DRUG

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

Placebo

Placebo will be administered via a sublingual pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Sufentanil

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-45 years of age
• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg
• Speak English

Exclusion Criteria

• Subjects not in the defined age range
• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Body mass less than 65 kg
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Subjects who cannot speak or read English
• Positive urine drug screen
• Currently taking pain modifying medication(s)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Craig Crandall

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute for Exercise and Environmental Medicine

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU-2021-0579

Identifier Type: -

Identifier Source: org_study_id