Ketamine for Sickle Cell Disease

NA
Overseen ByNatasha Archer, MD, MPH
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Boston Children's Hospital
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if the use of early ketamine decreases the chance of admission to the hospital in patients with sickle cell disease presenting with pain.

The main questions this study aims to answer are:

* Does ketamine given within 1 hour of acute care presentation decrease the chance of hospital admission?

* If admitted, does continuing ketamine in the first few hours of admission decrease opioid use or length of stay compared to those who start it later in the admission?

Researchers will compare the study arm to patients with sickle cell disease who receive placebo within 1 hour of presentation for the first aim.

Participants will be given ketamine/placebo by mouth without 1 hour of presentation.

If admitted, all participants will be able to start open label IV ketamine upon admission to the floor based on their clinical needs. Participants who end up starting ketamine will be reviewed to determine if early start to ketamine is helpful in reducing opioid use and length of stay.

Who Is on the Research Team?

NA

Natasha Archer

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient at study site
I am currently experiencing pain and have come to the emergency room or infusion clinic.
I am between 6 and 24 years old.
See 1 more

Exclusion Criteria

I have had severe side effects from ketamine.
Allergy to ketamine
I am not able to give my own consent for medical decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a single dose of oral ketamine or placebo within 1 hour of acute care presentation

1 day
1 visit (in-person)

Hospital Admission and Open-label Treatment

If admitted, participants may start open-label IV ketamine upon admission to the floor based on clinical needs

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including readmission rates and satisfaction surveys

14 days post discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral KetamineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+