The aim of this study is to compare Pethidine with Ketamine in treatment of postoperative shivering after ENT surgery. Inclusion criteria were ENT surgeries with general anesthesia and the exclusion criteria were receiving blood products or Metoclopramid, Obesity or hypertension. 90 patients, aged 15-50 years, (45 patients in each of the pethidine and ketamine group) who had developed 3-4 shivering in the recovery room were recruited in a prospective, randomized double blind study and randomly allocated to receive pethidine 25 mg, or ketamine 0/2 mg/kg, intravenously. Intensity of shivering was assessed from the first to tenth minute.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903034005N1
Registration date:2010-09-18, 1389/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-18, 1389/06/27
Registrant information
Name
Khosro Kolahdouzan
Name of organization / entity
Faculty of Paramedical Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 4777
Email address
kolahdozank@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pethidine with Ketamine in the Treatment of Postoperative Shivering after ENT surgery
Public title
Comparison of Pethidine with Ketamine in the Treatment of Postoperative Shivering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ENT surgeries with general anesthesia
Exclusion criteria: receiving blood products or Metoclopramide, Obesity, hypertension
Age
From 15 years old to 50 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-02-22, 1388/12/03
Ethics committee reference number
886
Health conditions studied
1
Description of health condition studied
Postoperative Shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Shivering
Timepoint
every minute for 10 minutes.
Method of measurement
Standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
ketamin 0.2mg/kg IV - after Appearance of shivering in recovery room
Category
Treatment - Drugs
2
Description
Petidine 25 mg- IV - after Appearance of shivering in recovery room
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital- Tabriz
Full name of responsible person
Dr Mahmoud Eidi
Street address
Tabriz
City
Tbriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Research Assistant
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahmoud Eidi
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Emam RezaHospital
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
eidy@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)