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 approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.

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 approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.

Treatment:

Drug: Fentanyl Citrate