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Safety and Efficacy Study of Dexmedetomidine in Pediatrics Ages >= 28 Weeks to <= 44 Weeks Gestational Age

2014-07-23 21:08:29 | BioPortfolio

Summary

The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥ 28 weeks to ≤ 44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive unit care unit (NICU), cardiac intensive unit care unit (CICU), or pediatric intensive unit care unit (PICU).

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Sedation

Intervention

Midazolam, Dexmedetomidine

Location

Children's Hospital of Pittsburgh of UPMC
Pittsburgh
Pennsylvania
United States
15224

Status

Not yet recruiting

Source

Hospira, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:29-0400

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Medical and Biotech [MESH] Definitions

A selective inhibitor of RECEPTORS, ADRENERGIC ALPHA-2 that has analgesic and sedative properties. MEDETOMIDINE is the other racemic form.

An agonist of RECEPTORS, ADRENERGIC ALPHA-2 that is used in veterinary medicine for its analgesic and sedative properties. It is the racemate of DEXMEDETOMIDINE.

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A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.

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Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


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