Sedation in PICU.
Conditions
Interventions
Intervention 1: Treatment group or group 1 : Clonidine with fixed dose 5 µg/kg every 6 hours via NGT(Abidi Pharmaceutical, Iran) plus with variable dose Fentanyl 0.5 - 2 µg/kg/hr and Midazolam 0.0
Treatment - Drugs
Treatment group or group 1 : Clonidine with fixed dose 5 µg/kg every 6 hours via NGT(Abidi Pharmaceutical, Iran) plus with variable dose Fentanyl 0.5 - 2 µg/kg/hr and Midazolam 0.05 - 0.1 mg/kg .
Control group: In this group , placebo is administered with variable dose Fentanyl 0.5 - 2 µg/kg/hr and Midazolam 0.05 - 0.1 mg/kg .
Sponsors
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
31 Days to 15 Years
Inclusion criteria
Inclusion criteria: Children with age of 31 days to 15 years requiring mechanical ventilation for 3 days.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of Fentanyl dosage. Timepoint: Total Fentanyl dosage based on 0.5 - 2 mcg/kg/hr in 24 hours up to end of ventilator support . Method of measurement: Ramsay Scale has 6 levels : level 1 anxious/agitated and level 6 deep sedation/ no response .Our goal is titrating Fentanyl to maintain patients on levels 2 - 3 (cooperative /respond to command ) .;Level of Midazolam dosage. Timepoint: Total Midazolam dosage based on 0.05 - 1 mg/kg in 24 hours up to end of ventilator support . Method of measurement: Ramsay Scale has 6 levels : level 1 anxious/agitated and level 6 deep sedation/ no response .Our goal is titrating Midazolam to maintain patients on levels 2 - 3 (cooperative /respond to command ) . | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects. Timepoint: daily. Method of measurement: observation on signes and symotoms. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Raha Khosravi
Pediatric Critical Care Unit
Outcome results
None listed