Effectivness of intravenous acetaminophen and ondansetron in prevention of postappendectomy shivering
Design
A randomized,blinded,sham controlled clinical trial with a parallel group design of 150 patients,in 3group includ acetaminophen,ondansetron and plasebo
Settings and conduct
150 Patients undergoing apendectomy surgery study randomly into three groups includ Acetaminophen,Ondansetron and Plasebo.Patients are not aware of the type of medication they receive.The method of randomization will be closed packed packages.For random allocation drugs in 3 group will be prepared every morning befor surgery by the presenter50 packet in 3 group A,B,C will chosen by nonaware person(Anesthetic technician)and will be injected to patients by Anesthetic Resident.In Acetaminophen group 15mg/kg and 8mg Ondansetron in Ondansetron group and 2cc Normal Salin in Plasebo group will be injected.Injectable solution volume in 3group will be equal(2cc).Post Operative shivering will be asked by Medicine Intern and pain and vomiting will be asked in recovery room and recorded in questionnaire.
Participants/Inclusion and exclusion criteria
Satisfaction to enter the study,Age between15_55,Class ASA I, II,exit requirement of study,
History of allergy to acetaminophen or ondansetron,Rynod syndrom,Hypothyroid,Hyperthyroid,Cardiovascular disease,psychologic disease,body temprature>38or<36
Intervention groups
15mg/kg up to 1gr acetaminophen and 8 mg ondansetron and 2 cc normal salin
Main outcome variables
Postoperative shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190226042852N1
Registration date:2019-07-27, 1398/05/05
Registration timing:registered_while_recruiting
Last update:2019-07-27, 1398/05/05
Update count:0
Registration date
2019-07-27, 1398/05/05
Registrant information
Name
Asra Fathollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4212 2064
Email address
asra.fathollahi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectivness of intravenous Acetaminophen and Ondansetron in prevention of postappendectomy shivering in general anesthesia method
Public title
Effectivness of intravenous Acetaminophen and Ondansetron in prevention of shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to enter the study
Age between15_55
Class ASA I, II
Exclusion criteria:
Exit requirement of study
History of allergy to Acetaminophen or Ondansetron
Rynaud syndrom
Hypothyroid or Hyperthyroid
Cardiovascular disease
Body temprature>38or<36
Age
From 15 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Convenience sampling determines the inclusion of patients to this study.These patients will be randomly investigated in 3 groups of Acetaminophen,Ondansetron and Placebo.Closed packets will be employed as randomization tool in this study.To randomize 3packs of A,B and C will be prepared based on the sample size and randomly injected to the patients while considering the pack codes.Prepartion of these 3medicines will be done by an anesthetic technician not having any part in the research and then rendered for injection by a person who is unaware of the syringe content.In Acetaminophen group 15mg/kg and 8mg Ondansetron in Ondansetron group and 2cc Normal Salin in placebo group will be injected.To apply blinding,Solution for injection will contain an equal volume of2cc for all the three groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Preparation of drugs will be done by Anesthetic technician who is no role in this study and injection will be done by person who nonaware of syringe matter.In Acetaminophen group 15mg/kg and 8mg Ondansetron in Ondansetron group and 2cc Normal Salin in plasebo group will be injected.Injectable solution volume in 3group will be equal(2cc).Another person who nonaware of type of injected drugs,evaluated patients post operative.Person who analize data not be aware of type of injected drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University ofMedical Sciences
Street address
university street,Ardabil
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR.ARUMS.REC.1396.255
Health conditions studied
1
Description of health condition studied
Effectivness of acetaminophen and ondansetron in prevention ofshivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
shivering
Timepoint
Postoperative
Method of measurement
grading of shivering
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous Acetaminophen
Category
Treatment - Drugs
2
Description
Intervention group: Intravenous ondansetron
Category
Treatment - Drugs
3
Description
Control group: Normal salin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Fatemi Hospital
Full name of responsible person
Asra Fathollahi
Street address
Dr Fatemi Hospital,Shariati street,Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2670
Email
Fatemi@arums.ac.ir
Web page address
http://www.arums.ac.ir/fatemi/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahab Bohloli
Street address
University street,Ardabil
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3352 2391
Fax
+98 45 3353 4773
Email
s.bohlooli@pharmacy.arums.ac.ir
Web page address
http://www.arums.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Hamed Zandian
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
univercity street,Ardebil university medicine sience
City
Ardebil
Province
Ardabil
Postal code
8599156189
Phone
+45 33 52 22 47
Fax
+98 45 3353 4773
Email
h.zandian@arums.ac.ir
Web page address
http://academic.arums.ac.ir/h-zandian/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ahmad Ghazi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
University street
City
Ardebil
Province
Ardabil
Postal code
8599156189
Phone
+98 224733524498
Fax
+98 45 3353 4773
Email
a.ghazi@arums.ac.ir
Web page address
http://www.arums.ac.ir/medicine/fa
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Asra Fathollahi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
shahid beheshti street,zonouz
City
zonouz
Province
East Azarbaijan
Postal code
5436119536
Phone
+98 41 4212 2064
Fax
+98 45 3353 4773
Email
asra.fathollahi@arums.ac.ir
Web page address
http://www.arums.ac.ir/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD