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Opioid Analgesic
Ketamine vs Fentanyl for Traumatic Injury Pain Management (PAIN Trial)
Phase 3
Recruiting
Led By Jason Sperry, MD
Research Sponsored by Jason Sperry
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intravenous pain medication indicated (CPOT>2, NRS>5) prior to arrival at the trauma center
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months +/- 1 month following trauma admission
Awards & highlights
PAIN Trial Summary
This trial will compare the outcomes of patients who receive ketamine or fentanyl for pain management in the prehospital setting.
Who is the study for?
The PAIN trial is for trauma patients with compensated shock (SI>0.9) who need IV pain medication and are being transported to a LITES Trauma center. It's not for those under 18, women under 50, anyone with high blood pressure (SBP>180 mmHg), prior pain meds or advanced airway management, prisoners, allergy to the drugs tested, or if they or family object.Check my eligibility
What is being tested?
This study tests how effective ketamine hydrochloride is compared to fentanyl citrate in managing pain for prehospital trauma patients with shock. Patients will be randomly assigned one of these medications without knowing which one they're getting during their transport to the hospital.See study design
What are the potential side effects?
Ketamine may cause changes in blood pressure, abnormal heart rhythms, hallucinations or confusion. Fentanyl can lead to slowed breathing, low blood pressure, drowsiness or nausea. Both drugs have risks that vary by individual.
PAIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I needed strong pain medication through an IV because of severe pain before getting to the trauma center.
PAIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24-hour mortality
Secondary outcome measures
24 hour opioid use
Baseline Pain/Anxiety/PTSD screening
Hospital length of stay
+13 moreSide effects data
From 2020 Phase 4 trial • 75 Patients • NCT031565041%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine
PAIN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine HydrochlorideExperimental Treatment1 Intervention
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
Group II: Fentanyl CitrateActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
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Who is running the clinical trial?
Jason SperryLead Sponsor
8 Previous Clinical Trials
5,891 Total Patients Enrolled
United States Department of DefenseFED
858 Previous Clinical Trials
224,627 Total Patients Enrolled
Jason Sperry, MDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
1,286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman under 50 years old.I or a family member have expressed concerns about participating in the study.I was taken to a PAIN Trauma center immediately after my injury.I needed strong pain medication through an IV because of severe pain before getting to the trauma center.I have had advanced airway management before my first dose.I have taken pain medication before joining this study.I am under 18 years old.I am allergic to fentanyl or ketamine.
Research Study Groups:
This trial has the following groups:- Group 1: Fentanyl Citrate
- Group 2: Ketamine Hydrochloride
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What dangers have been reported with Ketamine Hydrochloride exposure?
"There is existing clinical data that Ketamine Hydrochloride is safe for use, thus it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Met criteria
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