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Completed

NCT Number: NCT04040439

Precedex Special Investigation (in Pediatric Patients)

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

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Key information

Conditions

Sedation

Age range

45 week–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Japan Local Country Office

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

[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.

Other names: Precedex

Primary outcomes

  1. Number of Participants With Adverse Drug Reactions

    Time frame: 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).

    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.

Secondary outcomes

  1. Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician

    Time frame: At the end of administration of Precedex (up to Month 33, at the longest)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Maruishi Pharmaceutical

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2019
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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