NCT07450430

Optimal Timing of Ketamine Initiation for SCD Pain

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease
• Sickle Cell Crisis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-02-01
• Completion: 2030-02-01
• First posted: 2026-03-04
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study