This Phase III, randomised, triple-masked, parallel-group trial (n=90) will evaluate whether a single early oral dose of ketamine 0.5mg/kg (max dose of 35mg) given within 1 hour of presentation reduces the proportion of 6–24-year-olds with sickle cell disease presenting with acute pain who are admitted to hospital. The primary outcome is the percentage of participants admitted from the emergency department or infusion clinic within 6 hours of presentation. Participants are randomised to oral ketamine or placebo; the ketamine study drug is prepared from ketamine hydrochloride injection compounded into an oral solution and administered with taste-masking (either a Listerine strip before and after dosing or mixed with cherry syrup), while placebo is matching sterile water with the same masking. If participants are admitted, they may start open-label intravenous ketamine per clinical need and those who receive inpatient ketamine will be reviewed to assess effects on opioid use and hospital length of stay. Key eligibility includes a diagnosis of sickle cell disease, presentation with pain to ED or infusion clinic, age 6–24 years, and no ketamine allergy or contraindicating history. The study is planned to start in February 2026 with estimated completion in February 2030.
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.
Single dose of oral ketamine 0.5mg/kg (max dose of 35mg)