Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine
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|ClinicalTrials.gov Identifier: NCT04138615|
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Morphine Other: Placebo||Phase 4|
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 morphine 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||single-blinded placebo-controlled study|
|Primary Purpose:||Supportive Care|
|Official Title:||Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine|
|Actual Study Start Date :||November 12, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Morphine will be administered intravenously
Subjects will receive Morphine while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
Placebo Comparator: Placebo
Saline will be administered intravenously
Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
- Tolerance to simulated hemorrhage [ Time Frame: 19 months ]Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and morphine limbs, by causing progressive central hypovolemia via lower-body negative pressure. 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).
- Pain Assessment - Algometer [ Time Frame: 19 months ]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 when the subject has received placebo and morphine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138615
|Contact: Ileana Hill||214-345-6502||IleanaHill@texashealth.org|
|Contact: Joseph C Watso, PhDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Craig Crandall, PhD|