Precedex Special Investigation (in Pediatric Patients)

Pfizer

Status: Completed

Conditions: Sedation

Treatments: Drug: Dexmedetomidine Hydrochloride

Study type: Observational

Funder types: Industry

Identifiers

NCT04040439

C0801023

Details and patient eligibility

About

Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

Full description

To assess the data, including safety profile, of Precedex Intravenous Solution administered for "sedation during and after mechanical ventilation in the intensive care setting" in pediatric patients under actual medical practice in Japan.

Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each.

Enrollment: 111 patients

Sex: All

Ages: 45 weeks to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients (45 weeks corrected gestational age to <18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting.

Exclusion criteria

• No exclusion criteria is set out in this study.

Trial design

111 participants in 1 patient group

Dexmedetomidine Hydrochloride

Description:

Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation during and after mechanical ventilation in the intensive care setting"

Treatment:

Drug: Dexmedetomidine Hydrochloride