Ketamine Hydrochloride
Drugketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
NCT Number: NCT05437575
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
University of California, San Diego, San Diego, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
Time frame: trauma bay arrival through 24 hours
All cause mortality within 24 hours from time of trauma bay arrival
Time frame: from initial administration of PAIN prehospital analgesia through hospital arrival
incidence of hypoxia in the prehospital environment
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
incidence of hypotension in the prehospital environment
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
need for airway management in the prehospital environment
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
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: score assessed at time of arrival to trauma bay
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: from initial administration of PAIN study prehospital analgesia through hospital arrival
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 24 hours
total 24 hour opioid use
Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival
Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea
Time frame: administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
survival to hospital discharge
Time frame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 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
number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30
Time frame: 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission
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: from time of hospital admission to discharge
number of days recorded to the first decimal from hospital admission to discharge up to 30 days
Time frame: 0 hours to 2 weeks from time of hospital admission
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: 6 months +/- 1 month following trauma admission
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: At 3 and 6 months (+/- 1 month) after hospital arrival
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)
Contact information is provided by the study sponsor or research team.
Jason Sperry
Other
Acronym: PAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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