NCT05437575 Prehospital Analgesia INtervention Trial (PAIN)
| NCT ID | NCT05437575 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jason Sperry |
| Condition | Traumatic Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 994 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 994 participants in total. It began in 2023-11-27 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Jason Sperry, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05437575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05437575 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 994 participants.
Is NCT05437575 currently recruiting?
Yes, NCT05437575 is actively recruiting participants. Contact the research team at sperryjl@upmc.edu for enrollment information.
Where is the NCT05437575 trial being conducted?
This trial is being conducted at San Diego, United States, San Francisco, United States, Camden, United States, Charlotte, United States and 7 additional locations.
Who is sponsoring the NCT05437575 clinical trial?
NCT05437575 is sponsored by Jason Sperry. The principal investigator is Jason Sperry, MD at University of Pittsburgh. The trial plans to enroll 994 participants.