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NCT Number: NCT07450430

Optimal Timing of Ketamine Initiation for SCD Pain

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sickle Cell Crisis Signs and Symptoms Vaso-Occlusive Crises

Age range

6 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Primary outcomes

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

    Time frame: Within 6 hours of presentation

    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

Secondary outcomes

  1. Scores on brief surveys for satisfaction and side effects

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

    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)

    • 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

  2. Numerical Pain Rating Scale Scores

    Time frame: within 6 hours

    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.

Other outcomes

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

    Time frame: 30 days of admission

    Investigators will assess the average number of IV opioid administration days in ketamine versus placebo groups

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

    Time frame: Within14 days post discharge

    Investigators will assess clinical outcomes related to discharge including readmission to the ED, infusion clinic, or hospital.

  3. Length of stay of participants admitted when treated with ketamine/placebo

    Time frame: 30 days of admission

    Investigators will assess the length of stay of admitted participants treated with ketamine versus placebo.

Study contacts

Contact information is provided by the study sponsor or research team.

Natasha Archer, MD, MPH

CONTACT

[email protected]

617-355-6000 ext. x8246

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 4, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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