Prehospital Analgesia INtervention Trial (PAIN)

J

Jason Sperry

Status and phase

Enrolling
Phase 3

Conditions

Traumatic Injury

Treatments

Drug: Ketamine Hydrochloride
Drug: Fentanyl Citrate

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05437575
W81XWH- 6-D-0024 (Other Grant/Funding Number)
STUDY22010164

Details and patient eligibility

About

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) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.

Enrollment

994 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Trauma activation and transport from the scene of injury to a participating PAIN Trauma center
  • Patient with compensated shock as defined by Shock Index (SI) >0.9
  • Intravenous pain medication indicated (CPOT>2, NRS>5) prior to arrival at the trauma center

Exclusion criteria

  • No IV access
  • Age <18 years
  • Females <50 years of age
  • SBP>180 mmHg at time of enrollment
  • Received pain medication prior to enrollment
  • Advanced airway management prior to first dose administration
  • Known allergy to fentanyl citrate or ketamine hydrochloride
  • Known prisoner
  • Objection to study voiced by subject or family member at scene
  • Pain treatment contraindicated by local protocol
  • Wearing a "NO PAIN STUDY" bracelet

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

994 participants in 2 patient groups

Ketamine Hydrochloride
Experimental group
Description:
2 blinded doses 2.5mg/ml ketamine hydrochloride in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after 15 minutes if indication for pain management remains and there are no adverse events
Treatment:
Drug: Ketamine Hydrochloride
Fentanyl Citrate
Active Comparator group
Description:
2 blinded doses 10mcg/ml in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after 15 minutes if indication for pain management remains and there are no adverse events
Treatment:
Drug: Fentanyl Citrate

Trial contacts and locations

2

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Central trial contact

Jason Sperry, MD

Data sourced from clinicaltrials.gov

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