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Oral Ketamine for Treatment of Vaso-Occlusive Pain

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Phase changed: Phase 3 → Phase 1 Show 9 more changesShow less
    • Lead sponsor: Boston Children's Hospital to Boston Children's Hospital
    • Trial completed
    • Primary completion date changed from estimate of Jun 2026 to Nov 21, 2025
    • Start date: May 1, 2023 to May 26, 2023
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 7 of 8 entries
    • Eligibility criteria expanded, about 3 words
  2. Primary completion date: Dec 31, 2025 to Jun 2026v4
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study completion date: Jun 1, 2024 to Jun 1, 2026
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 1, 2023 to Dec 31, 2023
    • Start date changed from estimate of Jun 1, 2022 to May 1, 2023
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05378555
Lead Sponsor Boston Children's Hospital
Conditions
(from sponsor)		 Vaso-occlusive Crisis
Related terms Agnosia, Anemia, Sickle Cell, Vaso-Occlusive Crises
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov