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

NCT ID: NCT03621085

Last Updated: 2021-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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 ketamine 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

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Hemorrhage Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ketamine

Subjects will receive up to 20 mg Ketamine Hydrochloride while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.

Group Type EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type DRUG

A total of 20 mg of Ketamine Hydrochloride will be administered intravenously

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subjects will receive placebo

Interventions

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Ketamine Hydrochloride

A total of 20 mg of Ketamine Hydrochloride will be administered intravenously

Intervention Type DRUG

Placebo

Subjects will receive placebo

Intervention Type OTHER

Eligibility Criteria

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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

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
* 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

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United States Department of Defense

FED

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Craig Crandall

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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craig G Crandall, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Texas Health Presbyterian Hospital Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Watso JC, Huang M, Moralez G, Cramer MN, Hendrix JM, Cimino FA 3rd, Belval LN, Hinojosa-Laborde C, Crandall CG. Low dose ketamine reduces pain perception and blood pressure, but not muscle sympathetic nerve activity, responses during a cold pressor test. J Physiol. 2021 Jan;599(1):67-81. doi: 10.1113/JP280706. Epub 2020 Oct 20.

Reference Type BACKGROUND
PMID: 33017047 (View on PubMed)

Huang M, Watso JC, Moralez G, Cramer MN, Hendrix JM, Yoo JK, Badrov MB, Fu Q, Hinojosa-Laborde C, Crandall CG. Low-dose ketamine affects blood pressure, but not muscle sympathetic nerve activity, during progressive central hypovolemia without altering tolerance. J Physiol. 2020 Dec;598(24):5661-5672. doi: 10.1113/JP280491. Epub 2020 Oct 20.

Reference Type RESULT
PMID: 33084081 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STU 092017-068

Identifier Type: -

Identifier Source: org_study_id