Trial · NCT03621085

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

NCT03621085, Phase 4, Completed, University of Texas Southwestern Medical Center; results first posted 2021-11-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine. Trials, record NCT03621085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03621085

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine
NCT number: NCT03621085
Status: Completed
Phases: Phase 4
Enrollment: 43 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Hemorrhage, Healthy
Interventions: Ketamine Hydrochloride, Placebo
First posted: 2018-08-08
Last updated: 2021-11-26
Results first posted: 2021-11-26

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cumulative Stress Index	12 month	Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and ketamine 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).
Secondary	Pressure Pain Tolerance	12 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 after the subject has received placebo and ketamine.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cumulative Stress Index	12 month		mmHg x minutes	MEAN
SECONDARY	Pressure Pain Tolerance	12 months	Pressure pain tolerance was evaluated in a subset of individuals	Kilograms	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cumulative Stress Index	Ketamine	635	Standard Deviation 391	mmHg x minutes
Cumulative Stress Index	Placebo	649	Standard Deviation 362	mmHg x minutes
Pressure Pain Tolerance	Ketamine	3.3	Standard Deviation 1.0	Kilograms
Pressure Pain Tolerance	Placebo	1.6	Standard Deviation 0.6	Kilograms

Source ClinicalTrials.gov

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Enrollment	STARTED	Ketamine First, Then Placebo	22
Enrollment	STARTED	Placebo First, Then Ketamine	21
Enrollment	COMPLETED	Ketamine First, Then Placebo	16
Enrollment	COMPLETED	Placebo First, Then Ketamine	14
Enrollment	NOT COMPLETED	Ketamine First, Then Placebo	6
Enrollment	NOT COMPLETED	Placebo First, Then Ketamine	7
First Visit	STARTED	Ketamine First, Then Placebo	16
First Visit	STARTED	Placebo First, Then Ketamine	14
First Visit	COMPLETED	Ketamine First, Then Placebo	16
First Visit	COMPLETED	Placebo First, Then Ketamine	14

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Ketamine	30
Total, all-cause mortality	Placebo	30
Total, other adverse events	Ketamine	30
Total, other adverse events	Placebo	30
Total, serious adverse events	Ketamine	30
Total, serious adverse events	Placebo	30

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33017047	BACKGROUND	PubMed
33084081	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ketamine vs Placebo: deaths from any cause	Trial comparisons
Ketamine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03621085

GET https://conductscience.org/api/trials/v1/NCT03621085/flow?page=2

API reference For AI assistants