| 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
|
|
|
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
|
|
|
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. |