This study was designed to evaluate the effect of administration of intravenous (IV) ketorolac in comparison with Pethidine on shivering, during the first minutes following surgery in the recovery period.
This study was a randomized, double blind clinical trial in the third phase and single center. Sixty patients with American Society of Anesthesiologists physical status I and II, in the age range of 20 to 60 years who were scheduled for cholecystectomy under general anesthesia, were randomly assigned to two groups. Patients with hepatic and renal insufficiency, gastrointestinal bleeding, a need for blood transfusion during surgery, a history of allergy to non-steroidal anti-inflammatory drugs (NSAIDs) were excluded. When patients arrived to the operation room, they were randomly assigned to one of two equally divided groups (30 patients each) by using the closed envelop technique.
Group K received ketorolac (a non-selective COX inhibitor) 30 mg IV and group P received Pethidine (meperidine) 0.5 mg/kg IV, 20–30 minutes before completion of surgery.
The incidence and grades of postoperative shivering and pain intensity score were recorded during the recovery period. Postoperative shivering grades were evaluated 3 times in minutes 0, 5, 15. Other postoperative complications were asked in the questionnaire.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016080229162N1
Registration date:2016-09-09, 1395/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-09, 1395/06/19
Registrant information
Name
Neda Fathi
Name of organization / entity
Ardabil University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 3374 7222
Email address
ne.fathi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of ketorolac and pethidine on the postoperative shivering in patients undergoing cholecystectomy
Public title
Effect of Ketorolac in incidence of post operative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : abdominal surgeries (cholecystectomy); in the age range 20_60 years; American Society of Anesthesiologists (ASA) physical status I-II.
Exclusion criteria : Patients with cardiac, pulmonary, hepatic, renal, thyroid, or neuromuscular disease; those who took chronic drug or abused alcohol; operations that lasts more than 120 min; gastrointestinal bleeding; need for blood transfusion during surgery; a history of allergy to non steroidal anti-inflammatory drugs (NSAIDs) or other agents to be use; inability to cooperate.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Double-blind, randomized study was done by using sealed envelopes technique.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil
City
Ardabil
Postal code
56189-85991
Approval date
2015-12-19, 1394/09/28
Ethics committee reference number
IR. ARUMS.REC.1394.68
Health conditions studied
1
Description of health condition studied
cholecystectomy undergoing general anesthesia
ICD-10 code
K80, K81,
ICD-10 code description
Cholelithiasis, Cholecystitis, Other diseases of biliary tract
Primary outcomes
1
Description
check in scale of shivering
Timepoint
after operation in recovery ward on entrance and 5 and 15 minutes later
Method of measurement
score
Secondary outcomes
empty
Intervention groups
1
Description
Group intervention : 30mg ketorolac intravenously (IV)
Category
Treatment - Drugs
2
Description
Group control : 0.5mg/kg Pethidine (meperidine) intravenously (IV)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
-
Street address
Fatemi hospital, Imam Khomeini st., Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ardabil University of Medical Sciences
Full name of responsible person
Dr. Akbar Pirzadeh
Street address
Medical and Paramedical Faculty, Ardabil Univesity of Medical Sciences, Daneshgah st., Ardabil
City
Ardabil
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ardabil 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
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Neda Fathi
Position
Medical student
Other areas of specialty/work
Street address
Medical and Paramedical Faculty, Ardabil Univesity of Medical Sciences, Daneshgah st.,Ardabil
City
Ardabil
Postal code
-
Phone
+98 45 3323 6234
Fax
-
Email
ne.fathi@arums.ac.ir; nedafathi160@gmail.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Ghodrat Akhavan Akbari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Fatemi hospital, Imam Khomeini st., Ardabil
City
Ardabil
Postal code
5614733775
Phone
+98 45 3323 4682
Fax
-
Email
g.akbari@arums.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Neda Fathi
Position
Medical student
Other areas of specialty/work
Street address
Medical and Paramedical Faculty, Ardabil Univesity of Medical Sciences, Daneshgah st., Ardabil
City
Ardabil
Postal code
-
Phone
+98 45 3323 6234
Fax
-
Email
nedafathi160@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)