MedTrace Logo

Oral Ketamine for Treatment of Vaso-Occlusive Pain

NCT05378555 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-21

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2026-06-30
Completion
2026-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378555 on ClinicalTrials.gov