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

Not yet recruiting

• Conditions: Acute respiratory failure,

• Registration Number: CTRI/2022/02/040535

Brief Summary

We will be conducting a feasibility ,pilot, open label RCT to see if use of induction regimens containing ketamine reduce the incidence of tracheal intubation related adverse events in critically ill children. We will enrol eligible children aged 2months to 18 years admitted in pediatric wards, HDU and PICU of the department during the study period. The children will be randomised to 2 groups. One group will receive midazolam- fentanyl combination while the other will receive ketamine-midazolam combination prior to tracheal intubation.Both the groups will receive premedication of glycopyrrolate. Heart rate, ECG and blood pressure of the patients will be monitored at baseline and at 1,3,5,7,15,20 and 30 minutes after intubation. The child will be managed for the underlying illness as per the unit protocols. Primary and secondary outcome measures are measured.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-25
• Study Start: 2022-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

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

Known hypersensitivity to Ketamine -Hypertensive urgency and emergency -Craniofacial malformation -Mucopolysaccaridoses/ mucolipidoses -Pierre robin sequence -Down’s syndrome -History of face/neck trauma/burns/radiation -Neck masses -Patients presenting with cardiopulmonary arrest or being intubated for cardiopulmonary arrest.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 intubation	Before intubation and at o,1,3,5,7,10,15,20,25 and 30 minutes after endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
Incidence of other Tracheal Intubation associated Adverse Events (TIAEs) defined as trauma, emesis with or without aspiration, endobronchial/esophageal intubation, dysrhythmia, laryngospasm, pneumothorax	Trauma and laryngospasm will be assessed at the time of intubation.
Proportion of the encounters requiring neuromuscular blocker use	At the time of intubation
Proportion of encounters requiring repeat doses of sedatives to achieve adequate sedation	(State 1/2 as assessed using Pediatric Sedation State Scale)

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences, New Delhi

🇮🇳South, DELHI, India

Dr Sagar Tungal

Principal investigator

8447219790

sagartungal@gmail.com