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A study to compare the efficacy of dexmedetomidine and midazolam for sedation of mechanically ventilated children.

Dexmedetomidine versus Midazolam as a primary sedative in mechanically ventilated children: a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031988
Enrollment
44
Registered
2021-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z991- Dependence on respirator

Interventions

Intervention1: Dexmedetomidine: Children in dexmedetomidine group will receive intravenous dexmedetomidine infusion as primary sedation starting at 0.5 mcg/kg/hr, without a loading dose. Dose will be

Sponsors

Dr Mrinmayee Deshmukh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged 1 month to less than 18 years of age admitted to Pediatric Intensive Care Unit: who are mechanically ventilated using an endotracheal tube and requiring continuous sedation and intubation for at least next 24 hours (as anticipated by the treating team).

Exclusion criteria

Exclusion criteria: Neurologic injury or pathology/ chronic Central nervous system insult leading to prolonged or permanent weakness, Acute brain injury resulting in altered consciousness or cognitive dysfunction, Requirement of continuous Neuro-muscular blockade, Refractory shock, Bradycardia.

Design outcomes

Primary

MeasureTime frame
Percentage of children achieving target sedation scores in State Behavioural Scale score range ( minus 1 to plus 1) for both groups in first 48 hours.Timepoint: Percentage of children achieving target sedation scores in State Behavioural Scale score range ( minus 1 to plus 1) for both groups in first 48 hours.

Secondary

MeasureTime frame
To compare cumulative doses of sedative agents and opioids in the two groups.Timepoint: Up to end point of study;To compare drug withdrawal and adverse effects (hypotension, bradycardia, delirium) among the two groups.Timepoint: Withdrawal will be assessed upto 72 hours of start of assessment using Withdrawal Assessment Tool 1. other adverse effects shall be assessed upto end point of study;To compare Pediatric intensive care unit and hospital length of stay among the two groups.Timepoint: Up to hospital stay of patient;To compare the outcome between the two groups.Timepoint: Up to hospital stay of patient;To compare the time to extubation among two groups.Timepoint: Up to Pediatric Intensive Care Unit stay of patient.

Countries

India

Contacts

Public ContactDr Mrinmayee Deshmukh

Lady Hardinge Medical College

sguptabhu@gmail.com9779577087

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026