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Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children

NCT03668951 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-08

No results posted yet for this study

Summary

This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.

Conditions

  • Heart Diseases

Interventions

DRUG

Dexmedetomidine buccal

DEX 2 mcg/kg buccal

DRUG

Dexmedetomidine Intranasal

DEX 3 mcg/kg intranasal

DRUG

Dexmedetomidine Intranasal

DEX 4 mcg/kg intranasal

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jayant Pratap, MA,MB BChir,MRCPCH,FRCA · 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
2018-08-20
Primary Completion
2022-05-03
Completion
2022-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03668951 on ClinicalTrials.gov