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Clinical trials of Comparison the effect of two methods, patient controlled analgesia and non steroidal anti inflammatory drugs after elective cesarean section

Protocol summary

Summary
Clinical trials of comparison the effect of two methods, patient controlled analgesia and non steroidal anti inflammatory drugs after elective cesarean section; Objectives: Comparison the effect of two methods, patient controlled analgesia and non steroidal anti inflammatory drugs after elective cesarean section; Design: This clinical trial study, using purposive sampling method, was conducted on 100 elective cesarean section patients referred to Sadjad Hospital in Kermanshah city in 2014; Inclusion criteria: age between 20 to 35, no history of cesarean surgery, not suffering from chronic pain, BMI less than 30, no sensitivity to opioids drugs, chronic diseases and patient's written consent; Exclusion criteria: a history of addiction to opioids, history of liver and kidney diseases, the existence of mental illness verified by a physician and lack of interest or withdrawal during the conduction of the study; Intervention: Intervention group: namely injection by pump, analgesic pump contains 20 milligrams Morphine,16 milligrams Dexamethasone, 8 milligrams Ondansetron, 10 milligrams Chlorpheniramine, 200 milligrams Apotel and 2 milligrams which is diluted with normal saline to a volume of 100 cc. were injected by the patients at injection speeds of 8cc. Control group: whenever there analgesics were needed 100 milligrams Diclofenac was injected intramuscularly or Diclofenac suppository was used in turn; Main outcome measures variables: Postoperative pain

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2014091619197N1
Registration date: 2014-10-29, 1393/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-29, 1393/08/07
Registrant information
Name
Majid Ahmadi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3726 0606
Email address
majid.ahmadi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-08-28, 1393/06/06
Expected recruitment end date
2014-09-28, 1393/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of Comparison the effect of two methods, patient controlled analgesia and non steroidal anti inflammatory drugs after elective cesarean section
Public title
Clinical trials of Comparison the effect of two methods, patient controlled analgesia and non steroidal anti inflammatory drugs after elective cesarean section
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 to 35, no history of cesarean surgery, not suffering from chronic pain, BMI less than 30, no sensitivity to opioids drugs, chronic diseases and patient's written consent. Exclusion criteria: a history of addiction to opioids, history of liver and kidney diseases, the existence of mental illness verifiy by a physician and lack of interest or withdrawal during the conduction of the study.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The design of this study has not been randomly.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sadjad hospital
Street address
Bahar street, Kermanshah
City
Kermanshah
Postal code
-
Approval date
2014-08-26, 1393/06/04
Ethics committee reference number
SA-FC-00-0064

Health conditions studied

1

Description of health condition studied
postoperative pain
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
pain intensity
Timepoint
every 6 hours after intervention
Method of measurement
visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, namely injection by pump, analgesic pump contains 20 milligrams Morphine, which is diluted with normal saline to a volume of 100 cc. were injected by the patients at injection speeds of 8cc. They were instructed to press the infusion button to receive more medication as soon as feeling of pain started. By pressing the button, each time patient receives 0.5 cc serum-containing analgesics.
Category
Treatment - Drugs

2

Description
In the control group, whenever there analgesics were needed 100 milligrams Diclofenac was injected intramuscularly or Diclofenac suppository was used in turn (according to the available protocols).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadjad hospital
Full name of responsible person
Majid Ahmadi
Street address
Bahar street, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Majid Ahmadi
Street address
Bahar street, Kermanshah
City
Kermanshah
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Sadjad hospital
Full name of responsible person
Majid Ahmadi
Position
postgraduate student- responsible for OR
Other areas of specialty/work
Street address
Bahar street, Kermanshah
City
Kermanshah
Postal code
-
Phone
+98 83 3726 0606
Fax
-
Email
majid.ahmadi@muk.ac.ir; ahmadimajid1365@gmail.com; majid.ahmadi1986@yahoo.com
Web page address
www.ahmadimajid1365.blogfa.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sadjad hospital
Full name of responsible person
Majid Ahmadi
Position
postgraduate student
Other areas of specialty/work
Street address
Bahar street, Kermanshah
City
Kermanshah
Postal code
-
Phone
+98 83 3726 0606
Fax
-
Email
majid.ahmadi@muk.ac.ir; ahmadimajid1365@gmail.com; majid.ahmadi1986@yahoo.com
Web page address
www.ahmadimajid1365.blogfa.com

Person responsible for updating data

Contact
Name of organization / entity
Sadjad hospital
Full name of responsible person
Majid Ahmadi
Position
postgraduate student- responsible for OR
Other areas of specialty/work
Street address
Bahar street, Kermanshah
City
Kermanshah
Postal code
-
Phone
+98 83 3726 0606
Fax
-
Email
majid.ahmadi@muk.ac.ir; ahmadimajid1365@gmail.com; majid.ahmadi1986@yahoo.com
Web page address
www.ahmadimajid1365.blogfa.com

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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