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"

[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.

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.

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.

Pediatric patients (45 weeks corrected gestational age to <18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.

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.

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Precedex at least once. Participants with invalid registration or without informed consent were excluded.

Pediatric patients (45 weeks corrected gestational age to <18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion.