Ketamine for Sickle Cell Crisis

Overseen By Mohsen Saidinejad, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Mohsen Saidinejad

Must be taking: Opioids

Disqualifiers: Hypertension, Cardiovascular disease, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 3 days

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease experiencing sickle cell related pain. In this study, we will compare the outcomes (such as pain scores) in persons who receive standard of care pain medicine (an opioid such as morphine) plus a low dose (amount) of ketamine to those who receive only standard of care pain medicine.

Are You a Good Fit for This Trial?

This trial is for children and young adults with sickle cell disease who are experiencing pain due to a sickle cell crisis. Participants must be receiving standard opioid treatment for their condition.

Inclusion Criteria

I received pain medication before being asked to join the study.

Primary language is English or Spanish

I am able to give my consent, or if under 18, my parent/guardian can and I can agree if I'm able.

Exclusion Criteria

I have signs of high pressure inside my skull.

Oxygen saturation < 90% on room air

I do not have uncontrolled heart, liver, kidney, or thyroid disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard of care pain medicine plus a low dose of ketamine or only standard of care pain medicine

Up to 3 days

In-person during ED stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

4-6 weeks

1 visit (in-person or virtual) at 7-10 days, 1 visit (in-person or virtual) at 4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sub-dissociative Ketamine Infusion

Trial Overview

The study tests if adding a low dose of ketamine to standard opioid pain medication is more effective in managing pain during a sickle cell crisis compared to just the standard treatment.

How Is the Trial Designed?

Group I: Sub-dissociative Ketamine Experimental Treatment 1 Intervention

Participants receiving 0.25 mg/kg infusion of ketamine

Group II: Normal Saline Placebo Group 1 Intervention

Participants receiving 100 milliliters of normal saline

Who Is Running the Clinical Trial?

Mohsen Saidinejad

Lead Sponsor