Optimal Timing of Ketamine Initiation for SCD Pain

NCT07450430 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: P00047716
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sickle cell disease; ketamine; pain

Outcome Measures

Primary Outcomes (1)

• Percentage of participants admitted to the hospital from ED or infusion clinic

  Investigators will assess the effect of a single dose of oral ketamine compared to placebo administered within one hour of presentation on the percentage of participants admitted to the inpatient hospital unit

  Within 6 hours of presentation

Secondary Outcomes (2)

• Scores on brief surveys for satisfaction and side effects

  within 6 hours of receiving study drug/placebo (upon discharge from ED/Infusion)

• Numerical Pain Rating Scale Scores

  within 6 hours

Other Outcomes (3)

• Average number of IV opioid administration days in study drug/placebo groups

  30 days of admission

• Number of participants readmitted to the hospital within 14 days of discharge from ED, infusion clinic, or inpatient unit.

  Within14 days post discharge

• Length of stay of participants admitted when treated with ketamine/placebo

  30 days of admission

Study Arms (2)

Oral Ketamine

EXPERIMENTAL

Single dose of oral ketamine 0.5mg/kg (max dose of 35mg)

Drug: Ketamine hydrochloride injection

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Ketamine hydrochloride injection DRUG

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.

Also known as: Oral ketamine

Oral Ketamine

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 6 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• sickle cell disease diagnosis
• presenting with pain to ED or infusion clinic
• patient at study site
• to 24 years old

You may not qualify if:

• allergy to ketamine
• severe side effects associated with ketamine
• unable to consent

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Brookline, Massachusetts, 02445, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Natasha Archer

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Archer, MD, MPH

CONTACT

617-355-6000; natasha.archer@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: March 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)