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NCT02836431 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
A Phase 1 study of Heart Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02836431: Completed Phase 1 study of Heart Disease, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02836431 is a Phase 1 study of Heart Disease that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 18 participants, below the 2,046-participant average among 31 other Heart Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02836431, a Phase 1 study of Heart Disease, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
Primary Outcome
DEX concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax). Blood samples will be obtained at baseline, and 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, and 2 hours after receiving DEX. If cardiopulmonary bypass (CPB) is delayed beyond two hours, one final blood sample will be obtained immediately prior to CPB.
Conditions Studied
Interventions
- DRUG Dexmedetomidine 1mcg/kg Intranasal
- DRUG Dexmedetomidine 2mcg/kg Intranasal
- DRUG Dexmedetomidine 1mcg Intravenous
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-04 |
| Phase | Phase 1 |
What the finished NCT02836431 record still lists
NCT02836431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 2,046-participant average among 31 other Heart Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Heart Disease appearing as the primary indexed condition, and to 3 interventions - of which Dexmedetomidine 1mcg/kg Intranasal is the first listed.
NCT02836431 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02836431 about?
NCT02836431 is a clinical study titled "Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children". This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
What is the current status of trial NCT02836431?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-01. Estimated completion is 2018-04.
What conditions does trial NCT02836431 study?
This clinical trial studies the following conditions: Heart Disease.
What interventions are being tested in trial NCT02836431?
The interventions under investigation include: Dexmedetomidine 1mcg/kg Intranasal (DRUG), Dexmedetomidine 2mcg/kg Intranasal (DRUG), Dexmedetomidine 1mcg Intravenous (DRUG).
Who is sponsoring clinical trial NCT02836431?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02836431 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02836431's enrollment target sits among peer trials
18 32nd of 31 the lowest of 31 other Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Disease 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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