|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT2013042013069N1 |
|
Date of registration:
|
2013-09-22 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Suppository indomethacin and combined indomethacin- acetaminophen for pain after cesarean section
|
|
Scientific title:
|
Comparison of suppository indomethacin and combination of indomethacin- acetaminophen on post operative pain after cesarean section |
|
Date of first enrolment:
|
2013-03-06 |
|
Target sample size:
|
76 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/13005 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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.
|
|
Phase:
|
3
|
|
|
Countries of recruitment
|
|
Iran (Islamic Republic of)
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr. Mohammad Rasoul Ghadami
|
|
Address:
|
Imam Reza hospital, Sorkheh lizheh
Kermanshah
Iran (Islamic Republic of) |
|
Telephone:
|
+98 83 1427 6310 |
|
Email:
|
mrghadami@kums.ac.irmr_ghadami@yahoo.com |
|
Affiliation:
|
Kermanshah University of Medical Sciences |
|
|
Name:
|
Dr. Mohammad Rasoul Ghadami
|
|
Address:
|
Imam Reza hospital, Sorkheh lizheh
Kermanshah
Iran (Islamic Republic of) |
|
Telephone:
|
+98 83 1427 6310 |
|
Email:
|
mrghadami@kums.ac.irmr_ghadami@yahoo.com |
|
Affiliation:
|
Kermanshah University of Medical Sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
45 years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Delivery by caesarean section, unspecified
|
Post-cesarean pain.
Delivery by caesarean section, unspecified
|
|
Intervention(s)
|
|
Group A: A 50-mg indomethacin rectal suppository is administered immediately after a 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.
|
|
Intervention 1: Group A: A 50-mg indomethacin rectal suppository is administered immediately after a cesarean every 6 hours for 24 hours after the operation. Intervention 2: 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.
|
|
Treatment - Drugs
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
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.
|
|
Source(s) of Monetary Support
|
|
Kermanshah University of Medical Sciences, Vice chancellor for research
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Ethics committee, Kermanshah University of Medical Sciences
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|