BridgeMD
New treatment option for Traumatic Injury
Official title Prehospital Analgesia INtervention Trial (PAIN)
ClinicalTrials.gov ID: NCT05437575
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, being studied as a potential treatment for traumatic injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
- Camden, New Jersey, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Sayre, Pennsylvania, United States
- Salt Lake City, Utah, United States
- Burlington, Vermont, United States
- Milwaukee, Wisconsin, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; San Francisco, California, United States; Camden, New Jersey, United States; Charlotte, North Carolina, United States; Cincinnati, Ohio, United States; Pittsburgh, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.