| CTRI Number |
CTRI/2023/05/052577 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between sedative medication combinations Fentanyl -Ketamine and Midazolam -Ketamine for use in sedation in children during flexible bronchoscopy |
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Scientific Title of Study
|
Fentanyl- Ketamine versus Midazolam-Ketamine for sedation in children undergoing flexible fiber-optic bronchoscopy -An open label Randomized Controlled Trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/AIIMS BBSR /PG Thesis/2022-23/91 |
Protocol Number |
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Mohan Gulla |
| Designation |
Associate Professor Department of Pediatrics |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Department of Pediatrics
All India Institute of Medical Sciences Bhubaneswar
Sijua
Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9582273062 |
| Fax |
|
| Email |
ped_krishna@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Mohan Gulla |
| Designation |
Associate Professor Department of Pediatrics |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneswar |
| Address |
Department of Pediatrics
All India Institute of Medical Sciences Bhubaneswar
Sijua
Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9582273062 |
| Fax |
|
| Email |
ped_krishna@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopika Ramesh |
| Designation |
Junior Resident, Department of Pediatrics |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Pediatrics
All India Institute of Medical Sciences Bhubaneswar
Sijua
Patrapada
Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8606831254 |
| Fax |
|
| Email |
gopikaramesh067@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Bhubaneswar
Sijua Patrapada
Bhubaneswar
Odisha |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences BHUBANESWAR |
| Address |
AIIMS Bhubaneswar,
Sijua,
Patrapada ,
PO Dumduma,
Bhubaneswar,
Odisha |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKrishna Mohan Gulla |
Pediatric OPD Room No. 39 ,Ground floor , All India Institute of Medical Sciences,Bhubaneswar |
Pediatric OPD Room No. 39 ,Ground floor , All India Institute of Medical Sciences,Bhubaneswar
Sijua, Patrapada,
PO Dumduma,
Bhubaneswar,
Odisha
Khordha
ORISSA |
9582273062
ped_krishna@aiimsbhubaneswar.edu.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Bhubaneswar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl -Ketamine for sedation in children undergoing flexible fiberoptic bronchoscopy |
Ketamine at dose of 1mg/kg intravenous and fentanyl at dose of 1mcg/kg intravenous and additional dose of ketamine @1mg/kg intravenous will be given on the discretion of bronchoscopist and for duration of 10 minutes for sedation during flexible bronchoscopy in children and they will be assessed for primary, secondary outcomes
and followed up till hospital discharge
|
| Comparator Agent |
Midazolam-Ketamine for sedation in children undergoing flexible fiberoptic bronchoscopy |
Ketamine at dose of 1mg/kg intravenous and midazolam at dose of 0.1mg/kg intravenous and additional dose of ketamine @1mg/kg intravenous will be given on the discretion of bronchoscopist and for duration of 10 minutes for sedation during flexible bronchoscopy in children and they will be assessed for primary, secondary outcomes and followed up till hospital discharge |
|
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Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All children aged 6 months to 15 years admitted for flexible bronchoscopy in department of Pediatrics, AIIMS Bhubaneswar |
|
| ExclusionCriteria |
| Details |
1. Children with difficult airway
2. Children with hemodynamic compromise requiring vasoactive inotropic score >10
3. Children on respiratory support requiring FiO2>40% or high flow nasal cannula therapy
4. Children who require therapeutic procedures using flexible bronchoscopy like endobronchial biopsy, stent placement, balloon dilatation, foreign body removal
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Number of severe cough episodes during bronchoscopy in either group |
Time starting from the administration of sedative medications upto 20 minutes of bronchoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The time to achieve Ramsay sedation score 4 after administration of medication
2.Adverse effects of medications like hypotension,hypertension,bradycardia,tachycardia,hypoxemia
3.Bronchoscopy score
|
1.Time to achieve Ramsay sedation score 4 from the point of administration of sedatives
2.Vitals like heart rate,respiratory rate, Blood pressure,SpO2 5 minutes before administration of sedatives (baseline)
then every 5 minutes during and after bronchoscopy for 1 hour
3.Bronchoscopy score is recorded from administration of sedative medications till completion of bronchoscopy |
|
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Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
01/06/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Title : Fentanyl-Ketamine versus Midazolam-Ketamine for sedation in children undergoing flexible fiber-optic bronchoscopy – An open label Randomized Controlled trial
Rationale - Flexible fiberoptic bronchoscopy has become a crucial component in the diagnosis and treatment of acute and chronic pulmonary diseases in paediatric population. Sedation helps to induce and maintain appropriate amnesia, analgesia and muscle relaxation. It controls the behavior and movements of the subject and attenuate undesirable respiratory reflexes during procedure. The antitussive effect of opioids such as Fentanyl makes them more advantageous over other sedative agents like Midazolam for sedation in bronchoscopy. This study is to compare the efficacy of Fentanyl – Ketamine with Midazolam - Ketamine in controlling cough episodes during bronchoscopy and their safety.
Primary Objective :To compare the frequency of severe cough episodes during bronchoscopy in both groups Secondary Objectives 1. Assess time to achieve Ramsay sedation score 4 after administration of sedative 2. Assess adverse effects of sedatives 3. Assess bronchoscopist satisfaction regarding sedation
Methodology Study Design: Open Label, Randomized controlled trial Place of Study: Department of Pediatrics, All India Institute of Medical Sciences, Bhubaneswar Study Population: children aged 6 months to 15 years admitted to undergo flexible bronchoscopy in the Department of Pediatrics Randomization- with a computer generated random sequence Allocation concealment-serially numbered opaque sealed envelope (SNOSE) technique
Intervention: After consent/assent, children allocated to group A will be given Ketamine at dose of 1mg/kg and midazolam at dose of 0.1mg/kg and additional dose of ketamine @1mg/kg will be given on the discretion of bronchoscopist. Children allocated to group B will be given Ketamine at dose of 1mg/kg and Fentanyl at dose of 1mcg/kg and additional dose of ketamine @1mg/kg will be given on the discretion of bronchoscopist. Entire bronchoscopy procedure from the time of injection of sedative drugs till the completion of procedure will be videorecorded. Video of the procedure for severe cough episodes will be reviewed by adult pulmonologist who is not a part of the study. Adverse effects of sedatives through monitoring vital parameters like heart rate ,respiratory rate,SpO2 and Blood pressure and time required to achieve Ramsay sedation score 4 will be recorded. Bronchoscopy score is also derived to assess the satisfaction of bronchoscopist regarding sedation.
Statistical Analysis: Data will be entered into MS Excel, and analysis will be done using STATA (College Station, TX, US).
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