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Prehospital Analgesia INtervention Trial (PAIN)

NCT05437575 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 994

Last updated 2026-03-09

No results posted yet for this study

Summary

The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.

Conditions

  • Traumatic Injury

Interventions

DRUG

Ketamine Hydrochloride

ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe

DRUG

Fentanyl Citrate

fentanyl citrate 10mcg/ml packaged in pre-filled syringe

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Jason Sperry

    lead OTHER

Principal Investigators

  • Jason Sperry, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2028-07-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437575 on ClinicalTrials.gov