A Phase 3 interventional study of Ketamine Hydrochloride and Fentanyl Citrate in Traumatic Injury, sponsored by Jason Sperry. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Jason Sperry · Phase 3, Interventional, and Treatment
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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 994 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Jason Sperry is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.
Drug: Ketamine Hydrochloride
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 approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.
Drug: Fentanyl Citrate
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
24-hour mortality
All cause mortality within 24 hours from time of trauma bay arrival
Time frame: trauma bay arrival through 24 hours
Hypoxia
incidence of hypoxia in the prehospital environment
Time frame: from initial administration of PAIN prehospital analgesia through hospital arrival
Hypotension
incidence of hypotension in the prehospital environment
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
Need for airway management
need for airway management in the prehospital environment
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
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.
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
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.
Time frame: score assessed at time of arrival to trauma bay
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.
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
24 hour opioid use
total 24 hour opioid use
Time frame: from initial administration of PAIN study prehospital analgesia through 24 hours
Incidence of prehospital adverse events
Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
Survival to hospital discharge
survival to hospital discharge
Time frame: administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
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
Time frame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
Intensive Care Unit free days
number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30
Time frame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
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
Time frame: 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission
Hospital length of stay
number of days recorded to the first decimal from hospital admission to discharge up to 30 days
Time frame: from time of hospital admission to discharge
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)
Time frame: 0 hours to 2 weeks from time of hospital admission
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)
Time frame: 6 months +/- 1 month following trauma admission
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)
Time frame: At 3 and 6 months (+/- 1 month) after hospital arrival
Not enrolling at this site.
Plan to share: Yes — De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Supporting information: Study protocol, Informed consent form
Time frame: Data will become available after publication of the primary manuscript
Access criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Jul 2028, 56 months after the start.
Of 33 non-industry phase 3 interventional studies under Wounds and Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 55. This study's planned 56 months is above that.
Counting every sponsor, half of 37 studies reached it within 36 months; a quarter within 25 and three quarters within 55.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ketamine
Jason Sperry