Optimal Timing of Ketamine Initiation for SCD Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine hydrochloride injection, Placebo.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease, Sickle Cell Crisis. Basic parameters: 6 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Double-blind, Randomized, Placebo Controlled Study to Evaluate Optimal Timing of Ketamine Initiation
Overview
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.
Interventions
- Drug Ketamine hydrochloride injection
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. - Other Placebo
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.
Primary outcome measures
- Percentage of participants admitted to the hospital from ED or infusion clinic [Time frame: Within 6 hours of presentation]
Secondary outcome measures (2)
- Scores on brief surveys for satisfaction and side effects [Time frame: within 6 hours of receiving study drug/placebo (upon discharge from ED/Infusion)]
- Numerical Pain Rating Scale Scores [Time frame: within 6 hours]
Eligibility criteria
Inclusion criteria
- sickle cell disease diagnosis
- presenting with pain to ED or infusion clinic
- patient at study site
- 6 to 24 years old
Exclusion criteria
- allergy to ketamine
- severe side effects associated with ketamine
- unable to consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Children's Hospital — Brookline
Identifiers
NCT: NCT07450430 · P00047716