Prehospital Analgesia INtervention Trial (PAIN)

Traumatic Injury Clinical Trial

— PAIN  

Official title:

Prehospital Analgesia INtervention Trial (PAIN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437575
• Other study ID #: STUDY22010164
• Secondary ID: W81XWH- 6-D-0024
• Status: Recruiting
• Phase: Phase 3
• Start date: November 27, 2023
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Jason Sperry, MD
• Phone: 412-802-8270
• Email: sperryjl[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 994
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• Ketamine Hydrochloride
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
• Fentanyl Citrate
fentanyl citrate 10mcg/ml packaged in pre-filled syringe

Locations

Country	Name	City	State
United States	Allegheny Health Network (AHN) Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Jason Sperry	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour mortality	All cause mortality within 24 hours from time of trauma bay arrival	trauma bay arrival through 24 hours
Secondary	Hypoxia	incidence of hypoxia in the prehospital environment	from initial administration of PAIN prehospital analgesia through hospital arrival
Secondary	Hypotension	incidence of hypotension in the prehospital environment	from initial administration of PAIN study prehospital analgesia through hospital arrival
Secondary	Need for airway management	need for airway management in the prehospital environment	from initial administration of PAIN study prehospital analgesia through hospital arrival
Secondary	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.	from initial administration of PAIN study prehospital analgesia through hospital arrival
Secondary	Trauma bay arrival pain score	pain assessment using Numeric Rating Scale (NRS)/Critical Care Pain Observation Tool (CPOT) score. For Numeric Rating Scale, patients rate 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. A nurse will observe 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.	score assessed at time of arrival to trauma bay
Secondary	Number of analgesic doses necessary to reduce pain level to <5 NRS or CPOT less than 2	Number of analgesic doses necessary to reduce pain level to <5 on Numeric Rating Scale or less than 2 on Critical Care Pain Observation Tool. 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. A nurse will observe 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.	from initial administration of PAIN study prehospital analgesia through hospital arrival
Secondary	24 hour opioid use	total 24 hour opioid use	from initial administration of PAIN study prehospital analgesia through 24 hours
Secondary	Incidence of prehospital adverse events	Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea	from initial administration of PAIN study prehospital analgesia through hospital arrival
Secondary	Survival to hospital discharge	survival to hospital discharge	administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
Secondary	Ventilator free days	ventilator free days. Ventilator days are defined as number of days recorded to the first decimal spent on a mechanical ventilator subtracted from 30	from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
Secondary	Intensive Care Unit free days	number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30	from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
Secondary	Long term opioid use	long term opioid use assessed at 3 and 6 months. Patients who consent to further participation will be contacted to determine if they continued to use opioids (yes/no) at 3 and 6 months following trauma admission	3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission
Secondary	Hospital length of stay	number of days recorded to the first decimal from hospital admission to discharge up to 30 days	from time of hospital admission to discharge
Secondary	Baseline Pain/Anxiety/PTSD screening	A subset of patients who consent to further participation will be assessed for Anxiety/PTSD using the Four-Item Patient Health Questionnaire (PHQ-4) for anxiety and depression, a two item pain severity scale (0=no pain to 10=worst pain), and the Injured Trauma Survivor Screen (ITSS)	0 hours to 2 weeks from time of hospital admission
Secondary	Long term (6 month) outcome	A subset of patients who consent to further participation will be assessed for anxiety/depression/PTSD symptoms using the following tools: Generalized Anxiety Disorder (GAD-7), 8 item Patient Health Questionnaire (PHQ-8), and 8 item PTSD checklist (PCL-5)	6 months +/- 1 month following trauma admission
Secondary	Long Term Pain Assessment	A subset of patients who consent to further participation will be assessed for long term pain using a modified Brief Pain Inventory (numerical scale rating 0-10)	At 3 and 6 months (+/- 1 month) after hospital arrival