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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. 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.
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03296345
The ClinicalTrials.gov registry entry for NCT03296345 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketamine is the first listed.
NCT03296345 reports 0 study locations.
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.
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