Health Condition 1: null- critically ill children who are mechanically ventilated
Conditions
Interventions
Intervention1: Dexmedetomidine: All mechanically ventilated children age 1 month to 15
years within 1 hour of intubation
Control Intervention1: Midazolam: All mechanically ventilated children age 1 mo
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: All mechanically ventilated children age 1 month to 15 years within 1 hour of intubation
Exclusion criteria
Exclusion criteria: 1.Catecholamine resistant shock at time of randomization (Shock persists despite use of the directacting catecholamines i.e, epinephrine( >0.3 mcg/kg/min or norepinephrine >0.3mcg/kg/min) 2.Children who are already receiving infusion of sedation drugs(from the wards or referral hospital) 3.Severe bradycardia (HR 4.AV-conduction block (I,II,III types) 5.Children with primary nervous system involvement 6. Hepatic impairment ((a)evidence of a known chronic liver disease; (b)evidence of fulminant hepatic failure) 7. Need for muscle relaxation at the time of randomization(may only be used for intubation and initial stabilization) 8. Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of dexmedetomodine and midazolam for sedation of mechanically ventilated children 1 mon- 15 yr age admitted in PICUTimepoint: Level of sedation will be assessed every 3 hourly | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the following outcomes in mechanically ventilated children age 1 mon- 15 years receiving dexmedetomodine or midazolam for sedation a) Need for top up doses of sedatives b) Need for paralytic agents c) Adverse events (Bradycardia, Hypotension) d) Length of ICU stay(in days) e) Length of mechanical ventilation(in hours)Timepoint: continuously | — |
Countries
India
Contacts
Public ContactRakesh Lodha
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed