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NCT03296345 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis
A Phase 2 study, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT03296345: Completed Phase 2 study, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT03296345 is a Phase 2 study that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03296345, a Phase 2 study, has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist, ketamine mitigates this. Intravenous (IV) ketamine has demonstrated efficacy in reducing post-operative, chronic, and cancer-related pain in pediatrics, as well as in reducing time to pain control in the emergency department (ED) in adults. Limited studies suggest efficacy in adult opioid-refractory SCD patients. This study is investigating the safety and tolerability of adjuvant low-dose IV ketamine bolus for pediatric SCD VOE in the ED, as well as its efficacy in improving pain control and reducing hospitalization.
Primary Outcome
The number of serious and minor adverse events was measured via patient-completed survey as well as by nurse and medical providers on presentation to the emergency department (ED). Serious adverse events are defined as cardiorespiratory events requiring intervention. Minor adverse events are defined as nausea/vomiting, emergence reaction (dysphoria; hallucinations; frightening dreams), and a sense of de-realization or "dreamy" sensation. Both study providers and patients themselves, via a survey
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-04 |
| Phase | Phase 2 |
What the finished NCT03296345 record still lists
NCT03296345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT03296345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03296345 about?
NCT03296345 is a clinical study titled "Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis". Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist, ketamine mitigates this. Intra...
What is the current status of trial NCT03296345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2016-06. Estimated completion is 2018-04.
What interventions are being tested in trial NCT03296345?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT03296345?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03296345's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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