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NCT03950817 · ClinicalTrials.gov registry record · Phase 4
Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED
A Phase 4 study, sponsored by Antonios Likourezos.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT03950817 is a Phase 4 study that has completed, run by Antonios Likourezos. The registered enrollment target is 80 participants.
The verdict
NCT03950817, a Phase 4 study, has completed, sponsored by Antonios Likourezos.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
In the situation when intravenous access is not readily available or unobtainable, sub-dissociative dose ketamine can be administered via intranasal route (IN). The data supporting intranasal route in pediatric patients is somewhat conflicting with regards to the optimum intranasal dose (range 0.75-1 mg/kg) and frequencies of administration. Hence, another non-invasive route such as nebulization via Breath-Actuated Nebulizer which allows a controlled patient-initiated delivery of analgesics in titratable fashion might be considered in the ED. Administration of fentanyl via BAN for pediatric patients presenting to the ED with acute traumatic musculo-skeletal injuries was found to be safe and effective and comparable to intravenous fentanyl and intravenous morphine. Nebulized administration of ketamine however, has only been studied in the areas of acute postoperative pain management, cancer palliation, and status asthmaticus therapy (ref). To our knowledge, there are no prospective randomized trials that evaluated a role of nebulized SDK role in managing a variety of acute and chronic painful conditions in the ED.
Interventions
- DRUG Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg
- DRUG Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg
- DRUG Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2024-09-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03950817
The ClinicalTrials.gov registry entry for NCT03950817 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Antonios Likourezos, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg is the first listed.
NCT03950817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03950817 about?
NCT03950817 is a clinical study titled "Nebulized Sub-dissociative Dose Ketamine at Three Different Dosing Regimens for Treating Acute Pain in the Pediatric ED". In the situation when intravenous access is not readily available or unobtainable, sub-dissociative dose ketamine can be administered via intranasal route (IN). The data supporting intranasal route in pediatric patients is somewhat conflicting with regards to the optimum intranasal dose (range 0.75-...
What is the current status of trial NCT03950817?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2019-05-13. Estimated completion is 2024-09-24.
What interventions are being tested in trial NCT03950817?
The interventions under investigation include: Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg (DRUG), Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg (DRUG), Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg. (DRUG).
Who is sponsoring clinical trial NCT03950817?
This trial is sponsored by Antonios Likourezos, which has 33 total clinical trials registered on ClinicalTrials.gov.
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