Prehospital Analgesia INtervention Trial (PAIN) (PAIN)
Traumatic Injury
About this trial
This is an interventional treatment trial for Traumatic Injury focused on measuring Trauma, ketamine hydrochloride, fentanyl citrate, shock, pain
Eligibility Criteria
Inclusion Criteria:
- Trauma activation (Level I or Level II) and transport from the scene of injury to a participating LITES Trauma center
- Patient with compensated shock as defined by Shock Index (SI) >0.9
- Intravenous pain medication indicated (CPOT>2, NRS>5)
Exclusion Criteria:
- No IV access
- Age <18 years
- Females <50 years of age
- SBP>180 mmHg
- Received pain medication prior to enrollment
- Advanced airway management prior to first dose administration
- Known allergy to fentanyl citrate or ketamine hydrochloride
- Prisoner
- Objection to study voiced by subject or family member at scene
- Pain treatment contraindicated by local protocol
- Wearing a "NO PAIN" bracelet
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ketamine Hydrochloride
Fentanyl Citrate
2 blinded doses 2.5mg/ml ketamine hydrochloride in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after 15 minutes if indication for pain management remains and there are no adverse events
2 blinded doses 10mcg/ml in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after 15 minutes if indication for pain management remains and there are no adverse events