| CTRI Number |
CTRI/2022/02/040535 [Registered on: 23/02/2022] Trial Registered Prospectively |
| Last Modified On: |
25/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ketamine-midazolam vs fentanyl-midazolam combination for endotracheal intubation in sick children: a pilot randomised control trial |
|
Scientific Title of Study
|
Ketamine-midazolam vs fentanyl-midazolam combination as induction agents for tracheal intubation in critically ill children: a pilot, feasibility, open label, randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagar Tungal |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of medical Sciences, New Delhi |
| Address |
Department of paediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8447219790 |
| Fax |
|
| Email |
sagartugal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jhuma Sankar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Pediatric Pulmonology and Intensive care, Department of Pediatrics, All Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126546784 |
| Fax |
|
| Email |
jhumaji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jhuma Sankar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Pediatric Pulmonology and Intensive care, Department of Pediatrics, All Institute of Medical Sciences, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
01126546784 |
| Fax |
|
| Email |
jhumaji@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
Primary Sponsor
Modification(s)
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [No monetary assistance is needed for the study.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sagar Tungal |
All India Institute of Medical Sciences, New Delhi |
Pediatric ICU and HDU, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
South
DELHI |
8447219790
sagartungal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate education, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine and midazolam combination as induction regimen prior to endotracheal intubation |
Critically ill children requiring endotracheal intubation will receive a combination of ketamine (1mg/kg) and midazolam(0.1mg/kg) in boluses as induction agents prior to intubation. HR, ECG and BP will be recorded at baseline and at 1,3,5,7,10,15,20,25 and 30 minutes after intubation to look for adverse hemodynamic events. Other complications of intubation also will be recorded. |
| Comparator Agent |
Midazolam and fentanyl combination as induction regimen prior to endotracheal intubation |
Critically ill children requiring endotracheal intubation will receive a combination of midazolam(0.1mg/kg) and fentanyl(1microgram/kg) in boluses as induction agents prior to intubation. HR, ECG and BP will be recorded at baseline and at 1,3,5,7,10,15,20,25 and 30 minutes after intubation to look for adverse hemodynamic events. Other complications of intubation also will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
- 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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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.
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 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)
|
At the time of intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |