Comparison of sedation efficacy of the two sedative agents: Dexmedetomidine and Midazolam in critically ill children

Comparison of sedation efficacy of dexmedetomidine and midazolam in critically ill children - A single-blinded, parallel design, Randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068582

Enrollment

144

Registered

2024-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: J00-J06- Acute upper respiratory infections Health Condition 2: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities Health Condition 3: G35-G37- Demyelinating diseases of the central nervous system Health Condition 4: E08-E13- Diabetes mellitus Health Condition 5: G20-G26- Extrapyramidal and movement disorders Health Condition 6: D55-D59- Hemolytic anemias Health Condition 7: G00-G09- Inflammatory diseases of the central nervous system Health Conditi

Interventions

Intervention1: Dexmedetomidine: Route of administration: intravenous infusion Dose: starting @ 0.25mcg/kg/hr till maximum dose of 0.75mcg/kg/hr Duration: 5 days after enrolment or till extubation, wh

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 month to 15 years admitted in PICU, on invasive mechanical ventilation with an endotracheal tube, expected to be requiring sedation and ventilation for more than 24 hours and having a RASS score of = 1 at PICU admission

Exclusion criteria

Exclusion criteria: 1) Primary central nervous system disease 2) Hepatic impairment 3) Patients on neuromuscular blocker agent intravenous infusions 4) Post cardiac surgery patients in the first 48 hours of surgery with high risk of low cardiac output state 5) Patients diagnosed with atrio-ventricular conduction blocks or past history of the same 6) Previous participation in the study 7) Consent denial

Design outcomes

Primary

Measure	Time frame
Proportion of 2 hourly sedation data points in target range [ BIS target ? 40 to 70 / RASS target ? 0 to -4]Timepoint: 5 days from enrolment or till extubation whichever is earlier	—

Secondary

Measure	Time frame
Duration of mechanical ventilationTimepoint: till extubation;Incidence of bradycardia and hypotension while on sedative infusionTimepoint: 5 days of enrolment or till extubation, whichever occurs earlier;Incidence of Iatrogenic withdrawal syndromeTimepoint: 28 days of enrolment;Length of ICU stayTimepoint: discharge from ICU;Number of intermittent sedo-analgesic or neuromuscular agent bolus doses administered to maintain optimum sedation levelTimepoint: 5 days of enrolment or till extubation, whichever occurs earlier	—

Measure

Time frame

Duration of mechanical ventilationTimepoint: till extubation;Incidence of bradycardia and hypotension while on sedative infusionTimepoint: 5 days of enrolment or till extubation, whichever occurs earlier;Incidence of Iatrogenic withdrawal syndromeTimepoint: 28 days of enrolment;Length of ICU stayTimepoint: discharge from ICU;Number of intermittent sedo-analgesic or neuromuscular agent bolus doses administered to maintain optimum sedation levelTimepoint: 5 days of enrolment or till extubation, whichever occurs earlier

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Countries

India

Contacts

Public ContactVarun M Angadi

AIIMS Raipur

dratuljindal@gmail.com8224014667

Outcome results

None listed

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