Prehospital Analgesia INtervention Trial (PAIN)

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

• Transport after 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
• 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

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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