Premedication with oral paracetamol for reduction of propofol injection pain
Study ID: TCTR20150224002
Current status: Completed
Last Updated: February 24, 2017
Tracking Information
Date of Registration in Primary Registry: February 24, 2015
Date of First Enrollment: June 01, 2015 (Actual)
Target Sample Size: 324
Last Updated Date: February 24, 2017
Primary Outcome(s):
  • Outcome name: Severity of pain during propofol injection
       Metric/method of measurement: Verbal numerical rating score
       Time point: pre-post
       Safety Issue?: Yes


  • Key Secondary Outcomes:
  • Outcome name: The proper dose of oral paracetamol for reduction propofol injection pain
       Metric/method of measurement: Verbal numerical rating score
       Time point: pre-post
       Safety Issue?: Yes


  • Descriptive Information
    Public Title: Premedication with oral paracetamol for reduction of propofol injection pain
    Scientific Title: Premedication with oral paracetamol for reduction of propofol injection pain
    Brief Summary:
    Detailed Description:
    Study Design: Allocation: Randomized controlled trial
    Control: Placebo
    Study Endpoint Classification: Efficacy Study
    Intervention Model: Parallel
    Number of Arms: 3
    Masking: Double Blind (Masked Roles: Subject, Caregiver, Outcomes Assessor)
    Primary Purpose: Prevention
    Study Phase: N/A
    Health Condition(s) or Problem(s) Studied: none
    Study Arms:
  • Arm: 1
  • Intervention Name: Paracetamol 500 mg
    Type: Experimental
    Classification: Drug
    Descriptions: Patient received Paracetamol 500 mg 1 hr before the operation
  • Arm: 2
  • Intervention Name: Paracetamol 1000 mg
    Type: Experimental
    Classification: Drug
    Descriptions: Patient received Paracetamol 1000 mg 1 hr before the operation
  • Arm: 3
  • Intervention Name: Placebo
    Type: Placebo Comparator
    Classification: Drug
    Descriptions: Patient received Placebo 1 hr before the operation
    Recruitment Information
    Recruitment Status: Completed
    Estimated Enrollment: 324
    Study Start Date (First enrollment): June 01, 2015
    Primary Completion Date: January 01, 2016
    Inclusion Criteria:
    Inclusion Criteria
    Gender: Both
    Age Limit: Minimum 18 Years : Maximum 65 Years
    ASA class I III
    Elective surgery with general anesthesia
    IV insertion at dorsum of hand

    Exclusion Criteria
    Difficulty in communication
    BW below 50 kgs
    Patuents who have Hypertension Cardiovascular disease
    Renal failure or CrCl 10
    Hepatic failure or transminitis
    Allergy to paracetamol or propofol
    Infection on the dorsum of hand
    Patients who need a Rapid sequence induction for intubation
    Patients who refuse to join the study

    Accept Healthy Volunteers: No
    Countries of Recruitment Thailand
    Contact for Public Queries:
    Contact for Public Query's Name: Sasikaan - Nimmaanrat
    Degree: M.D.
    Phone: 0887907842        Ext: -
    Email: snimmaanrat@yahoo.com.au
    Postal Address: Prince of Songkla university Hat Yai
    State/Province: Songkhla        Postal Code: 90110
    Country: Thailand
    Administrative Information
    Primary Registry Site: Thai Clinical Trials Registry
    Trial Identification Number: TCTR20150224002
    Secondary Identifying Numbers: Nil known
    Source(s) of Monetary or Material Supports: Faculty of Medicine Prince of Songkla University
    Study Primary Sponsor: Faculty of Medicine Prince of Songkla University
    Study Secondary Sponsor: 1.) no
    Contact for Scientific Queries:
    Contact for Scientific Query's Name: Sasikaan - Nimmaanrat
    Degree: M.D.
    Phone: 0887907842        Ext: -
    Email: snimmaanrat@yahoo.com.au
    Postal Address: Prince of Songkla university Hat Yai
    State/Province: Songkhla        Postal Code: 90110
    Country: Thailand
    Track changes

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