Protocol summary

Summary
The aim of this study is comparing the effects of Ketorolac and Paracetamol on post-operative pain in lower limbs orthopedic surgeries. This is a randomized double blind clinical trial on 96 patients who are candidate of lower limbs surgery. Inclusion criteria: ASA classification I and II; age 18 to 65 years. Exclusion criteria: pregnancy; history of heart failure; kidney diseases; coagulation disorders; uncontrolled blood pressure. In this study 96 patients are included which be divided in 3 groups by simple sampling method (using randomized numbers table). The patients and observers (researchers) are blind to groups’ members. The participants are become familiar with the principle of visual analogue scale (VAS). The VAS of patient is evaluated before induction of anesthesia. The method of anesthesia is similar for all groups. Ten minutes before induction 30 mg ketorolac, 1gr paracetamol and, normal saline is administered in group 1, 2 and 3 respectively. In order to inhibition of narcotics interference with patient’s VAS in recovery room, no administration of fentanyl is done, 30 minutes to the end of anesthesia. In recovery room, VAS of the patient is obtained 45 minutes after patient’s consciousness. At the end of recovery period, the scores of VAS with all demographic information of the patients in all groups are documented and analyzed by statistic software and the effect of ketorolac and paracetamol on post-operative pain in lower limb surgeries is compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080712007N3
Registration date: 2015-08-23, 1394/06/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-23, 1394/06/01
Registrant information
Name
Mohammad Reza Doroudian
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1246 2055
Email address
mdoroudian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Kerman University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketorolac and paracetamol on post operative pain in patients undergoing lower limb orthopedic surgery
Public title
Comparison of ketorolac and paracetamol on post operative pain in orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA classification of I and II; age 18 to 65 years. Exclusion criteria: opioids and narcotics abuse for a long time; steroids consumption; pregnancy; history of heart, liver and kidney failure; coagulation disorders; uncontrolled hypertension; endocrine disorders (diabetes); BMI higher than 40; alcoholism; heart rate less than 40 b/m; surgical procedure up to 2 hours; asthma; GI bleeding.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 96
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 Kerman University Medical Sciences
Street address
Shafa Square
City
Kerman
Postal code
Approval date
2015-01-31, 1393/11/11
Ethics committee reference number
IR.KMU.REC.1394.122

Health conditions studied

1

Description of health condition studied
postoperative pain
ICD-10 code
M79.6
ICD-10 code description
Pain in limb

Primary outcomes

1

Description
Pain
Timepoint
45 minutes after consciousness
Method of measurement
VAS (visual analogue scale)

Secondary outcomes

1

Description
heart rate
Timepoint
every 15 minutes
Method of measurement
automatic monitoring device

2

Description
Blood pressure
Timepoint
Every 15 minutes
Method of measurement
Automatic monitoring device

Intervention groups

1

Description
One group will receive 1 gr intravenous paracetamol in 500 cc normal saline 10 minutes before induction of anesthesia
Category
Treatment - Drugs

2

Description
Second group will receive 30 mg intravenous ketorolac in 500 cc normal saline
Category
Treatment - Drugs

3

Description
In control group 500 ml normal saline will be given 10 minutes before induction of anesthesia
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Anis bahrami
Street address
Baghemelli Square
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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 Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Anis Bahrami
Position
Assistant of anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
anis_bahrami@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hosseyn Sattari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Bahonar Hospital, Baghemelli square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
hosattari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Anis Bahrami
Position
Assistant of anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
anis_bahrami@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...