Ketamine Hydrochloride for Traumatic Injuries

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Pittsburgh, Pittsburgh, PA
Traumatic Injuries+1 More
Ketamine Hydrochloride - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 1,544 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.

Eligible Conditions

  • Traumatic Injuries

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Traumatic Injuries

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 6 months following trauma admission

Month 6
Long term (6 month) PTSD outcome
Long term opioid use
Hour 24
24-hour mortality
Day 30
Survival to hospital discharge
Hour 72
Anxiety/PTSD screening
Day 30
Intensive Care Unit free days
Ventilator free days
Hour 24
24 hour opioid use
from initial administration of prehospital analgesia through hospital arrival
Hypotension
Hypoxia
Incidence of prehospital adverse events
Need for airway management
Number of analgesic doses necessary to reduce pain level to <5 NRS or CPOT less than 2
Prehospital pain assessment following analgesia
from time of hospital admission to discharge
Hospital length of stay
score assessed at time of arrival to trauma bay
Trauma bay arrival pain score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Traumatic Injuries

Side Effects for

Ketamine
1%Lightheadedness with low blood pressure
1%PTSD
1%Pump Malfunction
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03156504) in the Ketamine ARM group. Side effects include: Lightheadedness with low blood pressure with 1%, PTSD with 1%, Pump Malfunction with 1%.

Trial Design

2 Treatment Groups

Fentanyl Citrate
1 of 2
Ketamine Hydrochloride
1 of 2
Active Control
Experimental Treatment

1544 Total Participants · 2 Treatment Groups

Primary Treatment: Ketamine Hydrochloride · No Placebo Group · Phase 3

Ketamine Hydrochloride
Drug
Experimental Group · 1 Intervention: Ketamine Hydrochloride · Intervention Types: Drug
Fentanyl Citrate
Drug
ActiveComparator Group · 1 Intervention: Fentanyl Citrate · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~570

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months following trauma admission
Closest Location: University of Pittsburgh · Pittsburgh, PA
Photo of University of Pittsburgh Medical Center  1Photo of University of Pittsburgh Medical Center  2Photo of University of Pittsburgh Medical Center 3
2004First Recorded Clinical Trial
5 TrialsResearching Traumatic Injuries
646 CompletedClinical Trials

Who is running the clinical trial?

United States Department of DefenseFED
759 Previous Clinical Trials
200,616 Total Patients Enrolled
3 Trials studying Traumatic Injuries
1,187 Patients Enrolled for Traumatic Injuries
Jason SperryLead Sponsor
7 Previous Clinical Trials
4,841 Total Patients Enrolled
1 Trials studying Traumatic Injuries
1,020 Patients Enrolled for Traumatic Injuries
Jason Sperry, MDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
236 Total Patients Enrolled
1 Trials studying Traumatic Injuries
150 Patients Enrolled for Traumatic Injuries

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have pain that is not adequately controlled by oral medication.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.