The main objective of this study is comparison effect of pretreatment with Ondansetron, lidocaine and Paracetamol drugs on pain reduction due to interavenous injection of Propofol and Determination the best drug available to reduce injection pain of Propofol. The study is double-blind clinical trial.The target population will be patients who admitted to Besat hospital for elective general surgery. The sample size will be 164 patients in four groups, Each group 41 patients including the control group, ondansetron group, lidocaine group and paracetamol group. The premedication status in all groups before surgery will be quite similar and no additional medicines receive. patients in all study groups receive equal volume of medications by IV access number 20 on the largest vessel on the hand and after two minutes, a quarter of the total dose of Propofol 1% will injected during 20 seconds and During this period purpofol injection pain measuring by VRS(four-point Verbal Rating Scale ) which contains no pain = 0, mild= 1, moderate= 2, and severe=3. The site of drugs injection will be evaluated in term of pain, edema, allergic reactions and other side effects by the investigator over 2 hours after injection and record in the questionnaire
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015112325202N1
Registration date:2016-01-31, 1394/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-31, 1394/11/11
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisson effect of pretreatment with ondansetron, lidocaine and paracetamol drugs on pain reduction due to interavenous injectionof Propofol
Public title
Comparison of the three types of drugs to reduce propofol pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: " age 18 to 65 years" "patients with ASA class 1 and 2" " patients undergoing elective surgery"
Exclusion criteria:" (1) patients with ASA class of 3 or higher
2. Patients with a history of HTN and DM
3. Patients with a history of narcotic or psychotropic abuse or NSAID
4. The patient who are contraindicate for propofol, ondansetron, paracetamol and lidocaine drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
shahid fahmideh avenue
City
Hamadan
Postal code
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
Umsha.REC.1394.81 IR
Health conditions studied
1
Description of health condition studied
Acut pain after propofol injection
ICD-10 code
R52.0A
ICD-10 code description
pain, Vomiting, nausia
Primary outcomes
1
Description
Reduce the pain of Propofol injection
Timepoint
Along with propofol infusion in 20 seconds
Method of measurement
four-point verbal rating scale = VRS) which contains no pain = 0 , mild= 1 , moderate= 2 and severe =score 3 (by tearing or rejection injected organs or patient complain of pain or frown)
Secondary outcomes
1
Description
Check of pain and swelling and allergic reactions of drugs within 2 hours after injection were recorded in questionnair
Timepoint
within 2 hours after injection of drugs
Method of measurement
Observation and question
Intervention groups
1
Description
Intervention 1: Paracetamol: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro within 20 seconds will inject from the desired vein.
Category
Treatment - Drugs
2
Description
Intervention 2:ondancetronl: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro within 20 seconds will inject from the desired vein
Category
Treatment - Drugs
3
Description
Intervention 3: lidocain: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro within 20 seconds will inject from the desired vein
Category
Treatment - Drugs
4
Description
Control group: distilled water all steps will be similar to the intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mohammad zolhavarieh
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
parisa shirzad
Full name of responsible person
parisa shirzad
Street address
Hamadan University Of Medical Science
City
Hamadan
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
parisa shirzad
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University Of Medical Science
Full name of responsible person
Parisa Shirzad
Position
Student of anesthesia
Other areas of specialty/work
Street address
Hamadan Medical School
City
Hamadan
Postal code
Phone
+98 818138378247
Fax
Email
Fairyborn7@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University Of Medical Science
Full name of responsible person
Mohammad Zolhavarieh
Position
Anesthesiology MD
Other areas of specialty/work
Street address
Shahid Beheshti hospital
City
Hamadan
Postal code
Phone
+98 81 3838 0092
Fax
Email
dsmbszolhavarieh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Schol
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Other areas of specialty/work
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Postal code
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)