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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

Must not have

Females <50 years of age

Advanced airway management prior to first dose administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months +/- 1 month following trauma admission

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I needed strong pain medication through an IV because of severe pain before getting to the trauma center.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman under 50 years old.

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I have had advanced airway management before my first dose.

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I am under 18 years old.

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I am allergic to fentanyl or ketamine.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour mortality

Secondary study objectives

24 hour opioid use

Baseline Pain/Anxiety/PTSD screening

Hospital length of stay

+13 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

Awards & Highlights

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 contraindications

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 contraindications

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

0 / 5Eligibility criteria met