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NOT YET RECRUITING
NCT07450430
PHASE3

Optimal Timing of Ketamine Initiation for SCD Pain

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Double-blind, Randomized, Placebo Controlled Study to Evaluate Optimal Timing of Ketamine Initiation

Key Details

Gender

All

Age Range

6 Years - 24 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-02

Completion Date

2030-02

Last Updated

2026-03-09

Healthy Volunteers

No

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.

Locations (1)

Boston Children's Hospital

Brookline, Massachusetts, United States