Optimal Timing of Ketamine Initiation for SCD Pain

Part of paid clinical trials in Brookline, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07450430
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine hydrochloride injection — DRUG
    The drug will be compounded using Ketamine vial 10mg/ml. Either the participant will take one Listerine strip prior to drinking the ketamine injection solution and one Listerine strip after or the participant will drink a mixture of cherry syrup and ketamine injection solution together.
  • Placebo — OTHER
    The placebo will be prepared sterile water for a total matching volume of what the ketamine solution would have been. Either the participant will take one Listerine strip prior to drinking the ketamine injection solution and one Listerine strip after or the participant will drink a mixture of cherry syrup and ketamine injection solution together.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Dec 2025
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Ketamine
    Single dose of oral ketamine 0.5mg/kg (max dose of 35mg)
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of participants admitted to the hospital from ED or infusion clinic [ Time Frame: Within 6 hours of presentation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBrooklineMassachusetts02445
Natasha Archer
[email protected]
617-632-3023

Find similar trials in Brookline, MA

By condition
Sickle cell disease
By research site
Boston Children's Hospital· Brookline, MA

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