Precedex Special Investigation (in Pediatric Patients)

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040439
• Other study ID #: C0801023
• Status: Completed
• Start date: July 30, 2019
• Est. completion date: August 8, 2022

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Weeks to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sedation

Intervention

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.

Locations

Country	Name	City	State
Japan	Pfizer Japan Local Country Office	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Maruishi Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Drug Reactions	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Precedex in a participant who received Precedex. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Precedex was assessed by the physician.	From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest).
Secondary	Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician	Overall effectiveness of Precedex was evaluated at the end of Precedex administration by the physician. Clinical effectiveness was evaluated as effective, not effective, or indeterminate by the physician. Clinical effectiveness proportion was defined as the proportion of responders divided by the total number of responders and non-responders.	At the end of administration of Precedex (up to Month 33, at the longest)

External Links

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