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Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

NCT02836431 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-07-30

No results posted yet for this 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

Interventions

DRUG

Dexmedetomidine 1mcg/kg Intranasal

DEX 1 mcg/kg Intranasal

DRUG

Dexmedetomidine 2mcg/kg Intranasal

DEX 2 mcg/kg Intranasal

DRUG

Dexmedetomidine 1mcg Intravenous

DEX 1 mcg/kg Intravenously

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jeff Miller, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02836431 on ClinicalTrials.gov