Aim: Comparison of suppository indomethacin and combination of indomethacin- acetaminophen on post operative pain after cesarean section. In this study, 76 pregnant women undergoing elective cesarean section at Imam Reza hospital in Kermanshah are assessed. Inclusion criteria include elective cesarean section with lower uterine segment incision; pregnancy over 37 weeks. Patients are randomized to one of two groups: Group A: A 50-mg indomethacin rectal suppository is administered immediately after the cesarean every 6 hours for 24 hours after the operation. Group B: Two rectal suppositories (A 50-mg indomethacin and a 325-mg acetaminophen) are administered immediately after cesarean every 6 hours for 24 hours after the operation. Women randomized into two groups by 1:1 ratio method using a computer-generated random numbers. Variables consist pain, nausea and vomiting, need for analgesic and anti-emetic drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042013069N1
Registration date:2013-09-22, 1392/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Mohammad Rasoul Ghadami
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
mrghadami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-03-06, 1391/12/16
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of suppository indomethacin and combination of indomethacin- acetaminophen on post operative pain after cesarean section
Public title
Suppository indomethacin and combined indomethacin- acetaminophen for pain after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include elective cesarean section with lower uterine segment incision; pregnancy over 37 weeks.
Exclusion criteria include anemia, multiple pregnancies, poly hydramnious, prolonged labor, premature rupture of membranes, diabetes, high blood pressure, renal disease, history of drug abuse or smoking, cardiovascular diseases and coagulation disorders. or other underlying diseases.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Women randomized into two groups by 1:1 ratio using a computer-generated random numbers. Physician who evaluates the pain is blind to treatment interventions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Kermanshah University of Medical Sciences
Street address
Shahid beheshti Blvd. Build no. 2
City
Kermanshah
Postal code
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
420/پ/7/643
Health conditions studied
1
Description of health condition studied
Post-cesarean pain
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Pain severity
Timepoint
2, 4, 6, 12, 24 h after operation
Method of measurement
VAS with a 10-cm ruler is used and patient shows her pain on the ruler.
Secondary outcomes
1
Description
Nausea and vomiting, need for analgesic and anti-emetic
Timepoint
2, 4, 6, 12, 24 h after operation
Method of measurement
Ask from patient by resident
Intervention groups
1
Description
Group A: A 50-mg indomethacin rectal suppository is administered immediately after a cesarean every 6 hours for 24 hours after the operation.
Category
Treatment - Drugs
2
Description
Group B: Two rectal suppositories (A 50-mg indomethacin and a 325-mg acetaminophen) are administered immediately after cesarean every 6 hours for 24 hours after the operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
Sorkheh lizheh
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr. Farid Najafi
Street address
Vice chancellor for research, Build no. 2, Shahid Beheshti Blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences, Vice chancellor for research
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rasoul Ghadami
Position
General physician
Other areas of specialty/work
Street address
Imam Reza hospital, Sorkheh lizheh
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
mrghadami@kums.ac.irmr_ghadami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rasoul Ghadami
Position
General physician
Other areas of specialty/work
Street address
Imam Reza hospital, Sorkheh lizheh
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
mrghadami@kums.ac.irmr_ghadami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rasoul Ghadami
Position
General physician
Other areas of specialty/work
Street address
Imam Reza hospital, Sorkheh lizheh
City
Kermanshah
Postal code
Phone
+98 83 1427 6310
Fax
Email
mrghadami@kums.ac.irmr_ghadami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)