NCT04040439

Precedex Special Investigation (in Pediatric Patients)

Precedex(Registered) Intravenous Solution Special Investigation (in Pediatric Patients)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 111 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 45 Weeks – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Hydrochloride	\[Sedation during and after mechanical ventilation in the intensive care setting\] For pediatric patients ages of 6 years and over, dexmedetomidine is usually administrated by continuous intravenous (IV) infusion of at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. For pediatric patients with corrected gestational ages (gestational age + postnatal age) of 45 weeks to under 6 years, dexmedetomidine is usually administrated by continuous IV infusion at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. The dosing rate could be decreased according to the patient's condition as appropriate.

Timeline

• Start date: 2019-07-30
• Primary completion: 2022-08-08
• Completion: 2022-08-08
• First posted: 2019-07-31
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

1 site across 1 country: Japan