NCT03621085

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

Completed Phase 4 Results posted Last updated 26 November 2021

What this trial tests

Phase 4 trial testing Ketamine Hydrochloride in Hemorrhage in 43 participants. Completed in 30 June 2021.

Timeline

1 June 2018

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	supportive care
Enrollment	43
Start date	1 June 2018
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Ketamine Hydrochloride — full drug profile →
• Placebo

Conditions studied

• Hemorrhage — all drugs for Hemorrhage →
• Healthy — all drugs for Healthy →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 45, any sex, with Hemorrhage or Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cumulative Stress Index Primary · 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 th

Group	Value	95% CI
Ketamine	635	± 391
Placebo	649	± 362

Pressure Pain Tolerance Secondary · 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.

Group	Value	95% CI
Ketamine	3.3	± 1.0
Placebo	1.6	± 0.6

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparing the Effects of Low-Dose Ketamine, Fentanyl, and Morphine on Hemorrhagic Tolerance and Analgesia in Humans.
   Watso JC, Huang M, Hendrix JM, Belval LN, et al · · 2023 · cited 6× · PMID 36689353 · DOI 10.1080/10903127.2023.2172493
2. Sex Differences in Sympathetic Responses to Lower-Body Negative Pressure.
   Jarrard CP, Watso JC, Atkins WC, McKenna ZJ, et al · · 2024 · PMID 38233995 · DOI 10.1249/mss.0000000000003392