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Effect of naproxen on post-operative pain of thoracotomy, a randomized, blinded diclofenac control study

Protocol summary

Study aim
Effect of naproxen on post-operative pain of thoracotomy
Design
Randomized double blinded controlled study with 60 patients needing thoracotomy surgery that referred to Masih Daneshvari Hospital will be chooen and a code will be allocated to each one of them. Then, patients will randomly divided into three control and intervention groups.
Settings and conduct
This study was a blind, randomized, double blinded study that in the thoracotomy surgery department of Masih Daneshvari Hospital affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who are between 25 and 65 years of and in proper physical condition for thoracotomy surgery. Exclusion criteria: Patients with a history of gastric ulcer disease, bleeding disorders, kidney failure and patients that used nonsteroidal anti-inflammatory drugs.
Intervention groups
Intervention group1: Naproxen suppository 500 mg, 30-60 minutes before thoracotomy Intervention group 2: Diclofenac suppository 100 mg, 30-60 minutes before thoracotomy surgery Control group: not recieving any pain medication before surgery.
Main outcome variables
pain, Postoperative pain score is measured for all patients using the VAS technique in 0, 30, 60, 90 minutes, 2, 4, 6, 10, 24 hours after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160813029327N16
Registration date: 2018-07-28, 1397/05/06
Registration timing: retrospective

Last update: 2018-07-28, 1397/05/06
Update count: 0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of naproxen on post-operative pain of thoracotomy, a randomized, blinded diclofenac control study
Public title
Effect of naproxen on the post-operative pain of thoracotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are between 18 and 65 years of and in proper physical condition for thoracotomy surgery. Tendency to participate in the study and having consent form
Exclusion criteria:
Patients with a history of gastric ulcer disease Serious complications from non-steroidal anti-inflammatory agents Bleeding disorders Kidney failure Patients that used non-steroidal anti-inflammatory drugs.
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using Sequence Generator available at random.org three groups were made. Group 1 will receive Naproxen, Group 2 will receive Diclofenac, and Group 3 will be control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs are packed in to similar packages with ID codes; Physician, nurse, and investigators are not aware about package contents. Codes and labeling will be done by a third person.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Pharmaceutical Sciences
Street address
99, Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.IAU.PS.REC.1396.77

Health conditions studied

1

Description of health condition studied
Patients undergoing thoracotomy due to various conditions, eg. hydatic cyst, metastasis, mediastinal mass.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain evaluation
Timepoint
0, 30, 60, 90 minutes, 2, 4, 6, 10, 24 hours after surgery
Method of measurement
VAS (Visual Analogue Scale) technique

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group 1 receives 500 mg naproxen suppository 30-60 minutes before surgery.
Category
Treatment - Drugs

2

Description
The intervention group 2 receives diclofenac suppository 100 mg at the time of 30-60 minutes before surgery.
Category
Treatment - Drugs

3

Description
Control group: no pain medication before surgery will be used.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Shokoufeh Bayat
Street address
Pour Ebtehaj street, DarAbaad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
shekufeh.1993@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
No 99, Yakhchal Avenue, Shariati street
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Email
fhashemian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, the first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Email
r_abrishami@iaups.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, the first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Email
r_abrishami@iaups.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, the first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21226400515
Email
r_abrishami@iaups.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Patients' demographic data, Visual Analogue Scaleو Opioid consumption
When the data will become available and for how long
After publication of paper, for one year
To whom data/document is available
To academic persons
Under which criteria data/document could be used
User should cite the primary document
From where data/document is obtainable
Via email to corresponding author
What processes are involved for a request to access data/document
Sending email to corresponding author
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