Comparative study of the impact of infusion Apotel and Ketorolac in reducing postoperative pain and opioid consumption in patients undergoing orthopedic surgery of lower limbs.
The aim of this projection is comparative study of the impact of infusion Apotel and Ketorolac in reducing postoperative pain and opioid consumption in patients undergoing orthopedic surgery of lower limbs. It is a randomized double blind clinical trial.Patients and the person administering the drug do not know the type of medication. After obtaining written informed consent from all patients, 60 patients candidate for orthopedic surgery of lower limbs between 20 to 60 year with American society of Anesthesiologists(ASA) physical starus 1 or 2 entered this study. Patients with history of cardiovascular; pulmonary; renal failure; treatment with warfarin and pregnant women excluded from this study.From Balanced block method ;The patients were randomly devided into two groups, Apotel and Ketorolac groups. The first group used 1 g Apotel per 6 hours and the second used 90 mg Ketorolac stat. For analysing, we used from VAS system in 0; 12 and 24 hours after surgery. The end, Pain; Nousea and Vomiting; opioid consumption analysed.
General information
Acronym
Ketorolac and Apotel and reducing of pain
IRCT registration information
IRCT registration number:IRCT2017091231642N2
Registration date:2017-11-18, 1396/08/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-18, 1396/08/27
Registrant information
Name
Mohadese Esmailnejad
Name of organization / entity
Ardebil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3427 2643
Email address
m.esmaeil@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Ardabil University of Medical Sciences
Expected recruitment start date
2017-09-12, 1396/06/21
Expected recruitment end date
2017-09-27, 1396/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the impact of infusion Apotel and Ketorolac in reducing postoperative pain and opioid consumption in patients undergoing orthopedic surgery of lower limbs.
Public title
Comparative study of the impact of infusion Apotel and Ketorolac in reducing postoperative pain and opioid consumption in patients undergoing orthopedic surgery of the lower limbs.
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria: age 20-60 ; Score pain less than 8
Exit criteria: history of cardiovascular disease ; renal disease ; treatment with warfarin ; pregnant women
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Ardabil University of Medical Sciences
Street address
Ardebi University of Sciencesl, Daneshgahe st, Ardebil.
City
Ardebil
Postal code
53141_56198
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.ARUMS.REC.1396.46
Health conditions studied
1
Description of health condition studied
Postoperative pain of orthopedic surgery
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain.
Primary outcomes
1
Description
Receive pain medication
Timepoint
24 hours study
Method of measurement
Receiving an analgesic
2
Description
pain
Timepoint
12 and 24 hours after surgery
Method of measurement
Visual Analoge Scale(VAS) system
Secondary outcomes
empty
Intervention groups
1
Description
After orthopedic surgery of lower limbs, In first group, we use ; Ampul Apotel 1 gr IV per 6 hours.
Category
Treatment - Drugs
2
Description
In secound group of this study Ampul Ketorolac 90 mg in 1 lit Serum N/S infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi hospital in Ardebil
Full name of responsible person
Mina Mirzaei
Street address
Street Imam Khomeini, Shariati Sq, Fatemi Hospital
City
Ardebil
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.Maoud Entezari Asl
Street address
Ardebil University of Medical Sciences, Daneshgah st, Ardebil.
City
Ardebil
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
Ardebil University of Medical Sciences.
Full name of responsible person
Mina Mirzaei
Position
Medical student
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah St, Ardebil
City
Ardebil
Postal code
5613915537
Phone
+98 45 3324 1135
Fax
Email
minamirzai29@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil University of Medical Sciences.
Full name of responsible person
Dr. Godrat Akhavan Akbari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences, Daneshgah st, Ardebil.
City
Ardebil
Postal code
Phone
+98 45 3352 2083
Fax
Email
G.akbari@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardebil University of Medical Sciences.
Full name of responsible person
Mina Mirzaei
Position
Medical student.
Other areas of specialty/work
Street address
Ardebi University of Medical Sciences, Daneshgah st, Ardebil
City
Ardebil
Postal code
5613915537
Phone
+98 45 3324 1135
Fax
Email
Minamirzai29@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)