Protocol summary

Summary
The purpose of this study is comparison of the effects of Ketorolac, paracetamol and saline on the pain and the need for morphine in patients undergoing surgery via video thoracoscopy. This study is a randomized double-blind, placebo-controlled, and will be done on 93 patients candidates for video thoracoscopy surgery and are classified as class 1 to 3 of the Anesthesia Association of America, and do not have any history of heart failure or kidney failure or uncontrolled systemic disease. The patients receive the same anesthetic and sedation and , the patient transfer to the recovery room after the surgery and at that time the patients immediately undergo intravenous injection with paracetamol (apotel), Ketorolac and normal saline. The patients in the first 24 hours after surgery are under drug infusion. GroupA receives ketorolac,and group B receives Apotel and group C receives only saline in 24 hours. Patient pain intensity will be assessed with using a visual analogue scale rating of zero (no pain) to 10 (worst pain imaginable). Mean arterial pressure, heart rate and arterial oxygen saturation will be recorded at this time too. At the end the amount of morphine of the three groups will be compared. Complications such as bleeding in the first 24 hours after surgery, respiratory distress will recorded also.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062412642N14
Registration date: 2015-07-11, 1394/04/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-11, 1394/04/20
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research and Technology Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketorolac, paracetamol and saline on the pain and the need for morphine in patients undergoing surgery via video thoracoscopy
Public title
effect of ketorolac and paracetamol on pain in patients undergoing surgery via video thoracoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: All patients undergoing surgery via video thoracoscopy; Lack of heart failure; Lack of renal failure; Lack of uncontrolled systemic disease; lack of mental retardation; Lack of addiction to drugs and alcohol; lack of sychiatric disease and depression exclusion criteria: Lack of consent to participate in the study; Sensitivity to study drugs
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 93
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, Deputy for Research and Technology Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Postal code
Approval date
2015-06-09, 1394/03/19
Ethics committee reference number
FBMU1.REC.1394.113

Health conditions studied

1

Description of health condition studied
Effect of intravenous analgesics in patients undergoing surgery via video thoracoscopy
ICD-10 code
F44.6
ICD-10 code description
Dissociative anaesthesia and sensory loss

Primary outcomes

1

Description
Heart rate
Timepoint
Immediately after recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
in minute

2

Description
mean arterial pressure
Timepoint
Immediately after recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
mmHg with Using a mercury manometer

3

Description
pain
Timepoint
Immediately after recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Using a visual analogue scale of pain

Secondary outcomes

1

Description
amount use of morphine
Timepoint
24 passed after surgery
Method of measurement
According mg

2

Description
Saturation of arterial blood
Timepoint
Immediately after recovery and 2, 4, 8, 12 and 24 hours after surgery
Method of measurement
with pulse oxymetery

Intervention groups

1

Description
Group C: saline is administered after the end of surgery, then saline continues for 24 hours
Category
Prevention

2

Description
Group A: ketorolac 30mg is administered after the end of surgical, then ketorolac continues 90mg for 24 hours
Category
Prevention

3

Description
Group B: Apotel 1gr is administered after the end of surgical, then apotel continues 3gr for 24 hours
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Darabad Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research and Technology Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research and Technology Shahid Beheshti 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
Departman of Anesthesia Shahid Beheshti University Of Medical Science
Full name of responsible person
Alireza Jahangirifard
Position
Fellowship of Cardiac Anesthesia
Other areas of specialty/work
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
alirezajahangiri@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesia group, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialty intensive care
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
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
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