Oral Ketamine for Treatment of Vaso-Occlusive Pain

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT05378555
Phase
PHASE3
Status
Recruiting
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Conditions

  • Vaso-occlusive Crisis

Eligibility Criteria

Sex
ALL
Age
12 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine Hydrochloride — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine

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

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Christine Greco, MD
[email protected]
857-218-3556

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By research site
Boston Children's Hospital· Boston, MA

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