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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136548
• Other study ID #: STU 092017-069
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 1, 2019
• Est. completion date: November 18, 2020

Study information

• Verified date: January 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

With this background, we will test the hypothesis that fentanyl 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy

• Non-obese (body mass index less than 30 kg/m2)

• Body mass greater than or equal to 65 kg

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Healthy
• Hemorrhage

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pressure Pain Tolerance	Pain assessments will be conducted using a digital algometer to obtain maximum pain thresholds caused by pressure. This pain assessment technique is conducted by applying the tip of a hand-held digital algometer on the subject's digit. Force is gradually increased and the peak force is recorded when the subject first reports a painful sensation. Removal of the pressure from the algometer immediately relieves the painful sensation and the subject can voluntarily stop the test at any time. This assessment will be performed after the subject has received placebo and fentanyl.	12 months