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Ketamine-midazolam vs fentanyl-midazolam combination for endotracheal intubation in sick children: a pilot randomised control trial

Ketamine-midazolam vs fentanyl-midazolam combination as induction agents for tracheal intubation in critically ill children: a pilot, feasibility, open label, randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040535
Enrollment
100
Registered
2022-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: J960- Acute respiratory failure

Interventions

Intervention1: Ketamine and midazolam combination as induction regimen prior to endotracheal intubation: Critically ill children requiring endotracheal intubation will receive a combination of ketamin

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Critically ill children, age 2 month (corrected age) - 18 years admitted in wards, HDU and PICU - With one or more organ dysfunction AND - Requiring tracheal intubation - Patients who have already been enrolled before but are meeting inclusion criteria at a different time point and not on any sedative- analgesics at the time of current enrolment.

Exclusion criteria

Exclusion criteria: - Known hypersensitivity to Ketamine - Hypertensive urgency and emergency - Craniofacial malformation - Mucopolysaccaridoses/ mucolipidoses - Pierre robin sequence - Downââ?¬•s syndrome - History of face/neck trauma/burns/radiation - Neck masses - Patients presenting with cardiopulmonary arrest or being intubated for cardiopulmonary arrest

Design outcomes

Primary

MeasureTime frame
Incidence of adverse hemodynamic events defined as bradycardia defined as heart rate less than 60 minutes or hypotension requiring fluid bolus/inotrope or fall in systolic blood pressure by 30% of pre intubation value or increase in inotrope/vasopressor requirement by 30% from pre intubation requirement or cardiac arrest with or without ROSC from the beginning of induction up to 30 minutes after intubationTimepoint: Before intubation and at o,1,3,5,7,10,15,20,25 and 30 minutes after endotracheal intubation

Secondary

MeasureTime frame
Incidence of other Tracheal Intubation associated Adverse Events (TIAEs) defined as trauma, emesis with or without aspiration, endobronchial/esophageal intubation, dysrhythmia, laryngospasm, pneumothoraxTimepoint: Trauma and laryngospasm will be assessed at the time of intubation. Dysrhythmias and emesis will be assessed at baseline and at 0,1,3,5,7,10,15,20,25,30 minutes after endotracheal intubation Endobronchial intubation and pneumothorax will be confirmed by chest Xray after endotracheal intubation.;Proportion of encounters requiring repeat doses of sedatives to achieve adequate sedation (State 1/2 as assessed using Pediatric Sedation State Scale) Timepoint: At the time of intubation;Proportion of the encounters requiring neuromuscular blocker useTimepoint: At the time of intubation

Countries

India

Contacts

Public ContactDr Jhuma Sankar

All India Institute of Medical Sciences, New Delhi

jhumaji@gmail.com01126546784

Outcome results

None listed

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