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Optimal Timing of Ketamine Initiation for SCD Pain

NCT07450430 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Natasha Archer · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2029-02-28
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07450430 on ClinicalTrials.gov