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NCT05378555 · ClinicalTrials.gov registry record · Phase 3
Oral Ketamine for Treatment of Vaso-Occlusive Pain
A Phase 3 study of Vaso-occlusive Crisis, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05378555: Recruiting Phase 3 study of Vaso-occlusive Crisis, sponsored by Boston Children's Hospital.
NCT05378555 is a Phase 3 study of Vaso-occlusive Crisis that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 10 participants, below the 89-participant average among 4 other Vaso-occlusive Crisis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05378555, a Phase 3 study of Vaso-occlusive Crisis, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The Visual Analog Scale (VAS) will be used to measure pain. Scores are recorded on a line that represents a continuum between "no pain" and "worst pain."
Conditions Studied
Interventions
- DRUG Ketamine Hydrochloride
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 3 |
What NCT05378555 shows while recruiting
NCT05378555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 89-participant average among 4 other Vaso-occlusive Crisis trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Vaso-occlusive Crisis appearing as the primary indexed condition, and to 1 intervention - of which Ketamine Hydrochloride is the first listed.
NCT05378555 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05378555 about?
NCT05378555 is a clinical study titled "Oral Ketamine for Treatment of Vaso-Occlusive Pain". 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...
What is the current status of trial NCT05378555?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 2023-05-01. Estimated completion is 2026-06-01.
What conditions does trial NCT05378555 study?
This clinical trial studies the following conditions: Vaso-occlusive Crisis.
What interventions are being tested in trial NCT05378555?
The interventions under investigation include: Ketamine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT05378555?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05378555 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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