Clinical trial to compare sedation and analgesia rotation and non rotation protocol in mechanically ventilated children

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Rotation of sedative and analgesia drugs: In intervention group sedative and analgesic drugs will be rotated at specific time durations Patient on mechanical ventilation in PICU (sedation rotation group) Rotation1 Day 1 ‐ D ay 3 Midazolam‐ 2‐10µg/kg/min and fentanyl â?? 1‐4µg/kg/hr in infants, 1‐3µg/kg/hr in older children. (Rescue drug ‐Bolus of midazolam 0.1 ‐0.2 mg/kg). Rotation 2 Day 4‐ Day 6 ketamine‐1‐ 2mg/kg/hr and propofol‐1‐4mg/kg/hr (Rescue drug‐Bolus of midazolam0.1‐0.2mg/kg). Rotation 3 Day 7 ‐ Day 9 dexmedetomidine‐0.2‐1.5µg/kg/hr in infants,0.2‐1.5µg/kg/hr in older children and Clonidine â?? 3µg/kg/6hrly NG (maximum 5µg/kg/dose) (Rescue drug‐Bolus of midazolam 0.1‐0.2mg/kg). Day 10 ‐ Day 12 repeat rotation 1 (Rescue drug‐Bolus of midazolam 0.1‐0.2mg/kg). Day 13‐day 15 Repeat rotation 2 (Rescue drug‐Bolus of midazolam 0.1‐0.2mg/kg). Day 16‐ day 18 Repeat rotation 3 (Rescue drug‐Bolus of midazolam 0.1‐0.2mg/kg) Rotation cycle repeats againâ?¦... Control Intervention1: Non rotation of sedative and analgesic drugs: sedation and analgesia drugs in this group wont be rotated and same drugs will be given for whole duration of mechanical ventilation. Patients on mechanical ventilation in PICU (sedation non rotation group): Drugs: Dexmedetomidine‐0.2‐1.5µg/kg/hr in infants, 0.2‐1.5µg/kg/hr in older children and Fentanyl â?? 1‐4µg/kg/hr in infants,1‐3µg/kg/hr in older children (Rescue drug: Bolus of midazolam 0.1‐0.2mg/kg). CONDITION: Health Condition 1: Z991‐ Dependence on respirator PRIMARY OUTCOME: To compare the occurrence of withdrawal symptoms in sedation drug rotation protocol versus sedation with no rotation using WAT‐1 (withdrawal assessment tool version 1). ; Timepoint: After 1 year (March 2024) ; SECONDARY OUTCOME: 1.To compare the cumulative dose of midazolam needed as rescue therapy in both groups. ; 2.To compare the total duration of mechanical ventilation in each group. ; 3.To compare the total duration of PICU stay in each group.Timepoint: Till 1 year (March 2024) INCLUSION CRITERIA: 1.Children between one month to 18 years whose anticipated duration of requiring sedation and analgesia is for more than 3 days (72 hours). 2. Parents or guardians giving informed written consent for enrollment of child into study.
Epistemonikos ID: 902de05d5e1f65db9e57a85127dfee303e082af2
First added on: Feb 20, 2024