Optimal Timing of Ketamine Initiation for SCD Pain

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sickle Cell Disease; Sickle Cell Crisis
• Intervention / Treatment: Drug: Ketamine hydrochloride injection; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Natasha Archer, MD, MPH; Phone Number: x8246 617-355-6000; Email: natasha.archer@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Brookline, Massachusetts, United States, 02445
      • Boston Children's Hospital
      • Contact: Natasha Archer; Phone Number: 617-632-3023; Email: natasha.archer@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Experimental: Oral Ketamine; Single dose of oral ketamine 0.5mg/kg (max dose of 35mg)	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 Names: Oral ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on brief surveys for satisfaction and side effects	Investigators will assess the participant or guardian's satisfaction with pain treatment experience using a brief 2 question survey. Low scores are worse than high scores (min 0 and max is 5 for each question) 1. Please rate participant satisfaction with how well the study drug/placebo helped to relieve participant pain. (0 = Very Dissatisfied; 1 = dissatisfied; 2 = somewhat dissatisfied; 3 = somewhat satisfied; 4 = satisfied; 5=Very Satisfied) 2. Please rate how bothersome each of the following side effects were with the drug participant received If participant did not experience a side effect, please select, "Did not experience". (0=Extremely bothersome; 1 = bothersome; 2 = somewhat bothersome; 3 = mildly bothersome; 4 = not bothersome; 5 = Did not experience) Dysphoria, Dizziness, Unpleasant dreams, Hallucinations, Headache, Nausea, Other	within 6 hours of receiving study drug/placebo (upon discharge from ED/Infusion)
Numerical Pain Rating Scale Scores	Investigators will assess summed pain intensity difference (SPID) in numerical pain rating scale scores between study drug/placebo. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "worst pain imaginable"). 0 is the best outcome and 10 is the worst outcome.	within 6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of IV opioid administration days in study drug/placebo groups	Investigators will assess the average number of IV opioid administration days in ketamine versus 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.	Investigators will assess clinical outcomes related to discharge including readmission to the ED, infusion clinic, or hospital.	Within14 days post discharge
Length of stay of participants admitted when treated with ketamine/placebo	Investigators will assess the length of stay of admitted participants treated with ketamine versus placebo.	30 days of admission

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Natasha Archer, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pain; ketamine; sickle cell disease
• Additional Relevant MeSH Terms: Neurologic Manifestations; Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Pain; Anemia, Sickle Cell; Vaso-Occlusive Crises; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Ketamine
• Other Study ID Numbers: P00047716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No