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CTRI Number  CTRI/2019/03/017967 [Registered on: 07/03/2019] Trial Registered Prospectively
Last Modified On: 13/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the reduction of pain during iv cannulation using Lidocine spray or Buzzy device with conventional means of IV cannulation 
Scientific Title of Study   Comparison of Lidocaine spray, BUZZY® Device with Conventional technique to reduce pain of IV cannulation in paediatric patients : A Randomised Controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpa goyal  
Designation  Associate professor and guide 
Affiliation  All India institute of medical sciences, Jodhpur  
Address  Department of Anaesthesia and critical care, OPD block 3rd floor All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996880  
Fax    
Email  drshilpagoyal@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nehal c singh 
Designation  MD student  
Affiliation  Aiims Jodhpur’ 
Address  Department of Anaesthesia and critical care, OPD block 3rd floor All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9902961248  
Fax    
Email  nehalsingh248@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nehal C Singh 
Designation  MD student  
Affiliation  Aiims Jodhpur 
Address  Department of Anaesthesia and critical care, OPD block 3rd floor All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005

Jodhpur
RAJASTHAN
342005
India 
Phone  9902961248  
Fax    
Email  nehalsingh248@gmail.com  
 
Source of Monetary or Material Support  
All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 Shilpa goyal  AIIMS Jodhpur   Department of Anaesthesia and critical care, OPD block 3rd floor All India institute of medical sciences, HI Area Phase II, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 8003996880

drshilpagoyal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Buzzy device  patients will be cannulated with BUZZY® placed 2 min prior to procedure and 2 cm proximal to site of cannulation. 
Intervention  Lidocaine 10% spray  0.2ml of the 10% lidocaine spray will be sprayed over the site of venipuncture from a distance of 5 cm and 5 min before cannulation, dose 10 mg per puff of 0.1ml applied topically 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1.Paediatric patients of age 8-15 years requiring I.V cannulation.
2.Informed consent
3.Patient assent
 
 
ExclusionCriteria 
Details  1.Parent refusal
2.Known allergy to any of the medication used in the study.
3.Hemodynamically unstable patients.
4.Patients who received analgesics before 4 hours of the procedure.
5.Cracked or scaly skin
6. Local bruising and redness of the skin.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the pain scores during I.V. cannulation using Conventional method, Lidocaine 10% spray and Buzzy®.  1-5minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of IV cannulation   1-5 minutes  
Anxiety associated with cannulation  1-5 minutes  
Any side effects   10-15 minutes  
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/03/2019 
Date of Study Completion (India) 14/04/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/04/2020 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Peripheral  venous  cannulation is an everyday practice in the hospital and is painful. Inadequate pain relief is not only unpleasant for the patients but may cause anxiety about further treatment in the hospital. A study is planned to compare  the efficacy in reducing pain scores for paediatric iv cannulation  using lidocaine spray and Buzzy device. Under group A (CM) : patient will be cannulated in the conventional method where the site of cannulation will be wiped off with a swab of 70% alcohol. Under group B(LID) , 0.2ml of the 10% lidocaine spray will be sprayed over the site of venipuncture from a distance of 5 cm and 5 min before  the procedure.
Under group C(BUZZY®) patients will be cannulated with BUZZY® placed  2 min prior to procedure and 2 cm proximal to site of cannulation.The patient will be asked to rate the pain by pointing towards NRS- Numeric rating scale  for pain. Any side effects, procedural anxiety and ease of IV cannulation would be observed.

 
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