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CTRI Number  CTRI/2025/02/080311 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing Buzzy device and Lignocaine injection to reduce pain of propofol injection in children 
Scientific Title of Study   Prevention of pain on propofol injection in children using the Buzzy device versus pre injection with preservative free 2 percent Lignocaine, a randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavya KG 
Designation  Consultant Pediatric Anesthesiologist 
Affiliation  Rangadore Memorial Hospital 
Address  Rangadore Memorial Hospital, Department of Anesthesiology, 1st cross road, Shankarapuram, Basavanagudi, Bengaluru, Karnataka

Bangalore
KARNATAKA
560004
India 
Phone  9449004535  
Fax    
Email  drkavyakg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavya KG 
Designation  Consultant Pediatric Anesthesiologist 
Affiliation  Rangadore Memorial Hospital 
Address  Rangadore Memorial Hospital, Department of Anesthesiology, 1st cross road, Shankarapuram, Basavanagudi, Bengaluru, Karnataka


KARNATAKA
560004
India 
Phone  9449004535  
Fax    
Email  drkavyakg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kavya KG 
Designation  Consultant Pediatric Anesthesiologist 
Affiliation  Rangadore Memorial Hospital 
Address  Rangadore Memorial Hospital, Department of Anesthesiology, 1st cross road, Shankarapuram, Basavanagudi, Bengaluru, Karnataka


KARNATAKA
560004
India 
Phone  9449004535  
Fax    
Email  drkavyakg@gmail.com  
 
Source of Monetary or Material Support  
Dr Kavya KG No 2206, Kanika, Banashankari 2nd stage, Karesandra, Bengaluru 560070, Karnataka, India 
 
Primary Sponsor  
Name  Dr Kavya KG 
Address  No 2206, Kanika, Banashankari 2nd stage, Karesandra, Bengaluru, 560070, Karnataka, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavya KG  Rangadore Memorial Hospital  Department of Anesthesiology, Room 6, Operation Theater Complex, 1st floor, B block, Rangadore Memorial Hospital, 1st cross road, Shankarapuram, Basavanagudi, Bengaluru 560004
Bangalore
KARNATAKA 		 9449004535

drkavyakg@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rangadore Memorial Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, (2) ICD-10 Condition: M679||Unspecified disorder of synovium and tendon, (3) ICD-10 Condition: Q35-Q37||Cleft lip and cleft palate, (4) ICD-10 Condition: K02||Dental caries, (5) ICD-10 Condition: K35-K38||Diseases of appendix, (6) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, (7) ICD-10 Condition: M20-M25||Other joint disorders, (8) ICD-10 Condition: N30-N39||Other diseases of the urinary system, (9) ICD-10 Condition: Q53||Undescended and ectopic testicle, (10) ICD-10 Condition: Q54||Hypospadias, (11) ICD-10 Condition: Q65||Congenital deformities of hip, (12) ICD-10 Condition: Q90-Q99||Chromosomal abnormalities, not elsewhere classified, (13) ICD-10 Condition: S66||Injury of muscle, fascia and tendon at wrist and hand level, (14) ICD-10 Condition: T20-T25||Burns and corrosions of external body surface, specified by site, (15) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buzzy device  In this arm of the study of randomised group of patients, children receive Buzzy device which combines a gel ice pack to provide cold sensation and a bee like vibrating device providing vibration while also distracting children from pain during propofol injection 
Comparator Agent  Pre injection of preservative free 2% Lignocaine  In this arm of the study of randomised group of patients, children receive preservative free injection of 2% Lignocaine intravenously as a pre injection, prior to propofol injection 
 
Inclusion Criteria  
Age From  8.00 Month(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children aged 8 months to 10 years, males and females, belonging to ASA (American Society of Anesthesiologists) Physical status 1 and 2, undergoing surgery under General Anesthesia 
 
ExclusionCriteria 
Details  The following are the exclusion criteria - Crying children despite use of intravenous anxiolytic injection, shock, hypotension, bradycardia, allergy to egg lecithin, children on preoperative analgesics and children who need sevoflurane based inhalational induction for intravenous cannulation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assess the pain response to injection of propofol while using Buzzy device and compare it to the pain response seen with propofol injection when pre injection of preservative free 2% Lignocaine is given   Compare the Pain Scores between the two groups 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Assess change in heart rate to propofol injection while using Buzzy device & compare it with the change in heart rate to propofol injection when preinjection of preservative free 2 percent Lignocaine administered.  Compare the heart rate responses between the two groups 
 
Target Sample Size
Modification(s)  		 Total Sample Size="240"
Sample Size from India="240" 
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)   17/02/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkavyakg@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This study is a Double Blinded Randomised Controlled study which will be conducted in Rangadore Memorial Hospital, Bengaluru, Karnataka. It assesses prevention of propofol injection pain in children.
Propofol is a commonly used intravenous anesthetic for induction of general anesthesia and causes pain on injection. 
Children in the age group of 8 months to 10 years, belonging to ASA Physical statuses 1 and 2, undergoing various surgical procedures under General Anesthesia are included in this study and are randomly allocated to two different intervention groups. 
One group of the children in the study would receive propofol injection with Buzzy device. 
The other group of children in the study would receive a preinjection of preservative free 2% Lignocaine intravenously, prior to injection of propofol. 
Pain scores during propofol injection and hemodynamic parameters would be recorded in all patients. 
The Primary objective is to assess the pain response to injection of propofol and compare the pain responses between the two intervention groups. 
The Secondary objective is to assess change in heart rate to propofol injection while using Buzzy device and compare it with the change in heart rate to propofol injection when preinjection of preservative free 2% Lignocaine administered.
 
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