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Prehospital Analgesia INtervention Trial (PAIN)

ConditionTraumatic Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJason Sperry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Transport after injury to a participating PAIN Trauma center

2. Patient with compensated shock as defined by Shock Index (SI) ≥0.9 or Heart Rate (HR) ≥115.

Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the trauma center

Disqualifiers

No IV access

Age <18 years

Females <50 years of age

SBP>180 mmHg at time of enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine Hydrochloride

    Drug

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

  • Fentanyl Citrate

    Drug

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

Treatment groups

994 Participants
are divided into 2 treatment groups
Group A: Ketamine HydrochlorideExperimental treatment 1 intervention
Group B: Fentanyl CitrateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-hour mortality

All cause mortality within 24 hours from time of trauma bay arrival

Time frame
trauma bay arrival through 24 hours

Secondary outcomes

1

Hypoxia

incidence of hypoxia in the prehospital environment

Time frame
from initial administration of PAIN prehospital analgesia through hospital arrival
2

Hypotension

incidence of hypotension in the prehospital environment

Time frame
from initial administration of PAIN study prehospital analgesia through hospital arrival
3

Need for airway management

need for airway management in the prehospital environment

Time frame
from initial administration of PAIN study prehospital analgesia through hospital arrival
4

Prehospital pain assessment following analgesia

prehospital pain assessment using Numeric Rating Scale (NRS)/Critical Care Pain Observational Tool (CPOT) scores. For Numeric Rating Scale, the patient rates their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. The Critical Care Pain Observation Tool is used for patients who are intubated and cannot verbalize a pain score. Medical staff will observe the patient's behavior and score the patient's pain on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain.

Time frame
from initial administration of PAIN study prehospital analgesia through hospital arrival

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jason Sperry

Lead sponsor

University of Pittsburgh

Sponsor institution

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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