Actively Recruiting

Phase 3
Age: 12Years - 24Years
All Genders
NCT05378555

Oral Ketamine for Treatment of Vaso-Occlusive Pain

Led by Boston Children's Hospital · Updated on 2025-11-21

10

Participants Needed

1

Research Sites

161 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Oral Ketamine for Treatment of Vaso-Occlusive Pain

Who Can Participate

Age: 12Years - 24Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 12-24 years of age who require admission for vaso-occlusive pain
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

C

Christine Greco, MD

CONTACT

K

Kimberly Lobo, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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