Ketamine-midazolam vs fentanyl-midazolam combination for endotracheal intubation in sick children: a pilot randomised control trial
Not Applicable
- Conditions
- Health Condition 1: J960- Acute respiratory failure
- Registration Number
- CTRI/2022/02/040535
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
-Downââ?¬•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 intubationTimepoint: 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, pneumothoraxTimepoint: Trauma and laryngospasm will be assessed at the time of intubation. <br/ ><br>Dysrhythmias and emesis will be assessed at baseline and at 0,1,3,5,7,10,15,20,25,30 minutes after endotracheal intubation <br/ ><br>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 <br/ ><br>(State 1/2 as assessed using Pediatric Sedation State Scale) <br/ ><br>Timepoint: At the time of intubation;Proportion of the encounters requiring neuromuscular blocker useTimepoint: At the time of intubation