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COMPLETED Phase 1

Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

NCT02836431 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2016-01
Est. Completion 2018-04
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02836431

The ClinicalTrials.gov registry entry for NCT02836431 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02836431 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02836431?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial