Recruiting
Phase 3

Ketamine

Sponsor:

Boston Children's Hospital

Code:

NCT05378555

Conditions

Vaso-occlusive Crisis

Eligibility Criteria

Sex: All

Age: 12 - 24

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Study Details

Brief summary:

The purpose of this study is to learn more about the feasibility of oral ketamine for the treatment of painful sickle-cell crises in children and adolescents as a supplement to intravenous (IV) opioids. There is a need for improved non-opioid analgesia for patients experiencing sickle-cell crises in the hospital and prehospital setting, as children and adolescents with sickle cell disease who experience sickle-cell crises often have severe pain that is not well controlled by high dose opioids, leading to poor pain management and opioid-related side effects.

The study will begin when patients are admitted to the Emergency Department of Boston Children's Hospital for treatment of a sickle-cell crisis. Oral ketamine will be administered every 8 hours for the next 48 hours. Patients will have continuous cardiorespiratory monitoring for the duration of the study, as per routine care, as well as monitoring by the hospital's Acute Pain Service at least twice daily for pain management and side effects of pain treatment.

At the end of the 48-hour study duration, patients will discuss with the Pain Service and Hematology Service whether to continue oral ketamine, change to intravenous ketamine, or discontinue ketamine based on clinical indications such as level of pain and sedation while on opioids.

Conditions

Vaso-occlusive Crisis

Study ID

NCT05378555

Start date

May 1, 2023

Status verified date

Oct, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients 12-24 years of age who require admission for vaso-occlusive pain

Exclusion Criteria:

  • Patients who have had side effects to previous use of intravenous ketamine for treatment of vaso-occlusive pain that would preclude using ketamine for future pain episodes.
  • Patient refusal to participate

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine

Interventions

Ketamine Hydrochloride

All patients in this study will receive oral ketamine for the treatment of pain from vaso-occlusive crisis. Patients will receive 0.5 mg/kg ketamine Q8hrs for 48 hours.

Primary outcome measure

  • Change in pain intensity scores using the Visual Analogue Scale (VAS) Pain Score Scale [ Time Frame: Baseline, and then every 4 hours for 48 hours ]

Central Contacts and Locations

Central contacts

Christine Greco, MD

857-218-3556christine.greco@childrens.harvard.edu

Kimberly Lobo, MPH

857-218-3556kimberly.lobo@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Christine Greco, MD

857-218-3556christine.greco@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Nov 21, 2025

Last verified

Oct, 2025

Keywords

  • Ketamine
  • Sickle-cell disease
  • Opioid-sparing
  • Analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-11-21.