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
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
Treatments tested in this trial
- Ketamine Hydrochloride
- Fentanyl Citrate
Treatment groups
994 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jason Sperry
Lead sponsor
University of Pittsburgh
Sponsor institution
United States Department of Defense
Collaborator
Source ClinicalTrials.gov