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CTRI Number  CTRI/2025/07/091097 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two doses of oral paracetamol for reduction of pain on propofol injection during elective surgery. 
Scientific Title of Study   Comparative evaluation of two different doses of oral paracetamol in alleviation of pain on Propofol injection in patients undergoing elective surgery under general anaesthesia. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MD SALAUDDIN 
Designation  JUNIOR RESIDENT 
Affiliation  Pt. B D Sharma, PGIMS, Rohtak 
Address  Department of Anaesthesiology & Critical Care 2nd floor Modular OT complex Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8651569102  
Fax    
Email  MSRAZA000786@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandit Kad 
Designation  Professor 
Affiliation  Pt. B D Sharma, PGIMS, Rohtak 
Address  Department of Anaesthesiology & Critical Care 2nd floor Modular OT complex Pt. B D Sharma, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9896335544  
Fax    
Email  kadnandita@gail.com  
 
Details of Contact Person
Public Query
 
Name  MD SALAUDDIN 
Designation  JUNIOR RESIDENT 
Affiliation  Pt. B D Sharma, PGIMS, Rohtak 
Address  Department of Anaesthesiology & Critical Care 2nd floor Modular OT complex Pt B D Sharma PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8651569102  
Fax    
Email  MSRAZA000786@GMAIL.COM  
 
Source of Monetary or Material Support  
Pt. B D Sharma PGIMS,Rohtak, Haryana 124001 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical care 
Address  Department of Anaesthesiology And Critical Care 2nd floor Modular OT complex Pt B D Sharma PGIMS Rohtak Haryana 124001 India 
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 
Dr MD SALAUDDIN  Pt. B D Sharma, PGIMS, Rohtak  Department of Anaesthesiology & Critical Care 2nd floor Modular OT complex Pt. B D Sharma, PGIMS, Rohtak
Rohtak
HARYANA 
08651569102

MSRAZA000786@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committiee pt. B. D. Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tablet Paracetamol 500mg Tablet Paracetamol 650mg  Patient will be randomly allocated and one of the two groups. The pain score is based on assessment of patients’ motor and verbal reactions, from time of propofol injection to loss of consciousness. Pain is graded on a 0-6 point scale, with a score 2 considered unacceptable. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The study wil include 62 patients of either sex of age group 18-60 years, belonging to American Society of Anesthesiologists (ASA) physical status of 1-l posted for elective surgery under general anaesthesia of duration 1-3 hrs. 
 
ExclusionCriteria 
Details  History of allergy to test drug, History of hepatic and renal dysfunction, History of psychological disorders, History of alcohol and drug abuse, Refusal to participate in the study will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare and study of the effectiveness of two doses of oral paracetamol in alleviating
the pain due to propofol injection. 
inj. propofol 2mgkg-1 given intravenously as total dose. After one fourth of the total dose has been given the assessing anaesthesiologist will use a specially designed composite pain scale described by Rochette and colleagues to evaluate the level of propofol injection pain. 
 
Secondary Outcome  
Outcome  TimePoints 
To note side effects, if any.  24 hrs. 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   27/07/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Propofol is one of the most widely used intravenous anaesthetic agent for induction and maintenance of anaesthesia owing to its rapid onset and short duration. Propofol is an alkylphenol (2,6 diisopropylphenyl) oil at room temperature and insoluble in aqueous solution but is highly lipid soluble. Current formulation of 1% (weight/volume) propofol is available in 10% soybean oil, 2.25% glycerol, 1.2% purified egg phosphatide and disodium edetate 0.005% is added as a bacterial growth retardant. 

The pain on propofol injection is undesirable, the incidence of which varies between 28% to 90%. Pain on propofol injection can be immediate or can also be delayed after 10-20s. The immediate pain is due to irritation of skin, mucous membranes and venous intima which stimulates the nociceptors and free nerve endings. Some patients recall the induction of anaesthesia with propofol as the most painful part of the perioperative period. As a result, several interventions have been investigated to alleviate the pain associated with propofol injection. Many pharmacological agents like inj. lignocaine, inj. ondansetron or opioids such as fentanyl, NSAIDS and inj. ketamine have been tried. Some non-pharmacological approaches like selecting an antecubital vein instead of hand vein or adjusting the speed of intravenous carrier fluid have also been evaluated. These approaches have varying success rate. Paracetamol (acetaminophen) is a para-aminophenol that poses analgesic and antipyretic activity similar to aspirin. Paracetamol is thought to have a strong central action and there are speculations of peripheral effects as well. Paracetamol is one of the most commonly used drugs. Its availability is good, cost is low, and its uses include primary care prescribed therapy, secondary care application and emergency treatment. Stated benefits of paracetamol include: the drug’s analgesic effects, preference to aspirin in avoidance of Reye’s syndrome, good patient tolerance, and iatrogenic complications are infrequent and minor. Paracetamol is one of the most popular and frequently used pain killer throughout the world. The mechanisms of action are sophisticated and cover both peripheral and central antinociceptive manners. The pain relief effect provided by paracetamol is via inhibition of the cyclooxygenase pathway centrally and peripherally, reducing the production of prostaglandins. Paracetamol has been postulated to be classified to the group of the so-called atypical NSAIDs, determined as peroxide sensitive analgesic and antipyretic drugs (PSAAD). "Pain relieving effect of paracetamol might also be a result of inhibition of nitric oxide (NO) formation. The synthesis of NO is through activation of L-arginine/NO pathway by substance. P (SP) and N-methyl-D-aspartate (NMDA) receptors. NO is an important neurotransmitter involved in nociceptive process of the spinal cord. Previous study suggest that paracetamol metabolite N-acylphenolamine induces analgesic effect directly via transient receptor potential vanilloid 1 (TRPV1) receptor expressed on central terminals of C-fibers in the spinal dorsal horn and leads to conduction block, shunt currents, and desensitization of these fibers. A recent study observed that the addition of 2% lidocaine (20mg) to 1% propofol (10ml) caused macroscopic precipitation at 90 min due to the instability of the emulsion when the case was delayed for 90 min after its preparation. Another study postulated that oral paracetamol has been shown to increase the incidence of no pain as well as to reduce the incidence of severe pain upon propofol injection, the results of this study are clinically useful and applicable to daily practice because oral paracetamol is readily and widely available, practically simple and convenient to use as well as economical.

 
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