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CTRI Number  CTRI/2018/01/011562 [Registered on: 25/01/2018] Trial Registered Retrospectively
Last Modified On: 23/01/2018
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   A Comparative study to decrease incidence of pain on injection of propofol using newer preparations of propofol emulsion. 
Scientific Title of Study   A comparative randomized double blind study comparing effect of 0.5% dilution of propofol ( MCT/LCT) with 0.5 % dilution of propofol (LCT) on Injection Pain During Induction of anaesthesia in paediatric patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SAMEERA P 
Designation  POST GRADUATE MD 
Affiliation  VIMS 
Address  Department of Anaesthesiology VIMS Ballari Karnataka

Bellary
KARNATAKA
563122
India 
Phone  9742326961  
Fax  9742326961  
Email  sameerapatel7464@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR BALA SUBRAMANYA H 
Designation  PROFFESSOR, Department of anaesthesiology VIMS Ballari 
Affiliation  VIMS 
Address  Department of Anaesthesiology VIMS Ballari Karnataka

Bellary
KARNATAKA
583104
India 
Phone  9980600724  
Fax    
Email  halsanadu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRSAMEERA P 
Designation  POST GRADUATE MD 
Affiliation  VIMS 
Address  Department of Anaesthesiology VIMS, Ballari Karnataka #33, LVG block girls hostel VIMS Ballari

Bellary
KARNATAKA
583104
India 
Phone  9742326961  
Fax    
Email  sameerapatel7464@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology,Vijayanagar Institute of Medical Sciences, Ballari, Karnataka 583104 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences Ballari 
Address  Cantonment, Ballari 
Type of Sponsor  Government medical college 
 
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 
DrSameera  vijayanagar institute of medical sciences, Ballari  Department of Anaesthesiology, VIMS Ballari
Bellary
KARNATAKA 
9742326961
9742326961
sameerapatel7464@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee VIMS Ballari  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  children aged 6-12years under ASA 1 and 2 undergoing any elective surgical procedure under general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pain on injection of propofol LCT  Pain on injection of 0.5% propofol LCT in children aged 6-12 years under GA 0.5% Propofol LCT at a dose of 2mg/kg is used,after diluting 1% propofol LCT with 5% dextrose.  
Intervention  Pain on injection of propofol MCT/LCT  Pain on injection of 0.5% dilution of propofol MCT/LCT in children aged 6-12 years under GA. 0.5% Propofol MCT /LCT at a dose of 2mg/kg is used,after diluting 1% propofol MCT /LCT with 5% dextrose.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ASA 1 and ASA 2 patients 
 
ExclusionCriteria 
Details  ASA 3 and 4 patients
co existing systemic disease
contra indication to propofol 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of 0.5% dilution of propofol MCT/LCT with propofol LCT for injection pain during induction of general anaesthesia (GA) in paediatric patients.  15 seconds, 30 seconds and 1 minute intervals.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of 0.5 % dilution of propofol MCT/LCT with propofol LCT on haemodynamic changes during induction of GA in both the groups.  15 seconds, 30 seconds and further at 1 minute intervals upto 5 minutes after induction  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2016 
Date of Study Completion (India) 16/11/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None as of now 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Propofol is the most frequently used IV anaesthetic today. Propofol, when  used for induction of anaesthesia in brief  procedures, results in a significantly  quicker  recovery  and  an  earlier  return  of  psychomotor  function  compared  with  other  induction  agents.  Induction  ofanaesthesia  is associated with several  side  effects with pain during intravenous injection being major among them. In view of  the  above  consideration,  this  clinical  study  was  performed  to  assess  the  comparative effects of 0.5% dilution of propofol MCT/LCT with 0.5% dilution of propofol LCT on injection pain.

A  hundred  ASA  physical  status  I  &  II  patients ,aged 6-12 years,  both  male  and  female  posted for various elective surgeries under general anaesthesia were studied. 

 

 

 

         The patients were divided into two groups of fifty each:

         Group LCT &Group MCT/ LCT (N = 50 ), according to the computer generated list.

         Group LCT received  0.5% dilution of propofol (LCT) at 2mg/kg 

     Group MCT/ LCT received 0.5% dilution of propofol (MCT LCT) at 2mg/kg

 Pain on propofol injection was assessed using Mc Crirrick and Hunter scale of evaluation of propofol  injection pain.The patients  in  both groups were comparable with  respect  to  demographic  and  hemodynamic parameters.Our study showed that 66% of group MCT/LCT and 12% of group LCT had no pain at all. While 8% in group MCT/LCT and 4% in group LCT had mild pain. The patients who experienced moderate pain were 18% in group MCT/LCT and 54% in group LCT,while only 8% had severe pain in group MCT/LCT compared to 30% in group LCT The difference in pain on injection was significantly less in group 0.5% MCT/LCT compared to group 0.5%  LCT with P value of 0.0000 being highly significant. Hence we can conclude that using 0.5% dilution of propofol MCT/LCT has significantly reduced the incidence,intensity and severity of pain on propofol injection.

 
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