Clinical trial of comparison between the effect of paracetamol (Apotel) and meperidine ( pethidine) on the pain in the first 24 hours after cesarean section.
Objectives:Comparison between analgesic effect of paracetamol (Apotel) and meperidine ( pethidine) in the first 24 hours after cesarean section.
Design:Randomized clinical trial.
Setting and conduct:Double blind.
Participants:Inclusion criteria: all patients after cesarean section with normal body mass index( between 18.5 and 25).
Exclusion criteria: Drug abuse; history of allergy to paracetamol or mepiridine; history of hepatitis;renal failure ; heart failure, respiratory disease;CNS disorders; coagulopathy; sedative use; psychiatric disorders and complication of cesarean section.
Interventions:Administration of paracetamole (Apotel) and mepiridine( Pethidine).
Main outcome:Pain relief in the first 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405262624N17
Registration date:2015-04-25, 1394/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison between the effect of paracetamol (Apotel) and meperidine ( pethidine) on the pain in the first 24 hours after cesarean section.
Public title
Analgesic effect of paracetamol and meperidine after cesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients after cesarean section with normal body mass index( between 18.5 and 25).
Exclusion criteria: Drug abuse; history of allergy to paracetamol or mepiridine; history of hepatitis; renal failure; heart failure; respiratory disease;CNS disorders; coagulopathy; sedative use; psychiatric disorders and complication of cesarean section.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethic comittee of Iran University of Medical Sciences
Street address
Hemmat highway, Chamran Cross
City
Tehran
Postal code
16117
Approval date
2012-09-23, 1391/07/02
Ethics committee reference number
92/د/130/ 2592
Health conditions studied
1
Description of health condition studied
Cesarean delivery
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Pain .
Timepoint
0-1-2-4 and 6 hours after drug administration.
Method of measurement
VAS
Secondary outcomes
1
Description
need to more analgesic
Timepoint
0-1-2-4 and 6 hours after drug administration.
Method of measurement
questionair
2
Description
Paracetamol adverse effects.
Timepoint
0-1-2-4 and 6 hours after drug administration.
Method of measurement
VAS
3
Description
side effects of meperidine
Timepoint
0-1-2-4 and 6 hours after drug administration.
Method of measurement
VAS
Intervention groups
1
Description
Intervention group: After finishing cesarean section and in the recovery room , pain of the patient has been determined using VAS . Then diclofenac suppository 100 milligram plus paracetamol ( Apotel) ampule has been prescribed 1 mg every 8 hours ( infusion in 100 ml normal saline during 15 minutes).
Category
Treatment - Drugs
2
Description
Control ( mepiridine) group: After finishing cesarean section and in the recovery room , pain of the patient has been determined using VAS . Then diclofenac suppository 100 milligram plus mepiridine ( pethidine) 50 mg has been prescribed every 6 hours intramuscularly.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Iran University of Medical Sciences.
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Hemmat High way, Chamran Cross.
City
Tehran
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 ,Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Other areas of specialty/work
Street address
Molavi Avenue, Molavi Cross.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)