Introduction: Cesarean section in Iran is two times higher than the global statistics. Diclofenac rectal suppository as analgesic has not the opioid and gastro intestinal side effects. This study was performed to show Effect of Diclofenac rectal suppository on Pentazocin intake for releife pain after cesarean.
Material and methods: This study was performed by RCT method. RCT was done on 80 women that undergo the cesarean section, by the same anesthesia method, and were selected randomly in two groups of 40 persons of diclofenac and Pentazocin. In diclofenac group imediately after cesarean section, rectal suppository Diclofenac 100mg, and in 12, 24 and 36 hours after surgery, the rectal suppository Diclofenac 50mg was used and is necessary for more relief pain was injected the Pentazocin Amp 30mg IM. Also in Pentazocin group for pain relief according to the routine method was injected the Pentazocin Amp 30mg IM. For both two groups, the number of Pentazocin was used and pain severity was measured by Visual Analog Scale (VAS) in 3,12 an 24 hours after surgery and discharge time, and then was determind the drugs side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206176826N3
Registration date:2012-07-13, 1391/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-13, 1391/04/23
Registrant information
Name
Mahshid Bokaie
Name of organization / entity
Shahid Sadougi university of medical sciences,Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
mah_bokaie@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2010-02-19, 1388/11/30
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ِِDiclofenac rectal suppository in Pentazocin intake in pain after cesarean section in patients referred to Shahid Sadougi Hospital
Public title
Effect of ِِDiclofenac rectal suppository in Pentazocin intake in pain after cesarean section in patients referred to Shahid Sadougi Hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-35 years old pregnant women; second or third time of cesarean section; single fetus and gestational age 37-42 week.
Exclusion criterion: every complication during Anastasia and operation
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study was carried out by randomized controlled trial (RCT) method on 80 qualified cesarean women under identical anesthetic conditions; the statistical population was randomly divided into two 40-persons groups, i.e. Diclofenac and Pentazocine. In Diclofenac group, the first Diclofenac rectal suppository was deployed immediately after cesarean and next suppositories were inserted 12, 24 and 36 hours following the operation; 30mg muscular Pentazocine ampoule was injected as sedative where necessary. In Pentazocine group, only 30 mg muscular Pentazocine was injected for pain sedation as routine. For two groups, number of administered Pentazocine, pain intensity in 12, 24 and 36 hours after operation and discharge time were measured by means of visual-analogue scale (VAS) of pain evaluation, and, side effects of medicines were determined as well.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadougi University of Medical Sciences
Street address
Bahonar squ- Yazd
City
Yazd
Postal code
Approval date
2010-01-14, 1388/10/24
Ethics committee reference number
92097
Health conditions studied
1
Description of health condition studied
Post cesarean pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Pain severity
Timepoint
12, 24 and 36 hours and discharge time.
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Numder of amp pentasocine (30 mg) used
Timepoint
Till discharge time
Method of measurement
Number of amp
Intervention groups
1
Description
Diclofenac Na rectal supp 50 , 100mg
Aborayhan factory
after cesarean section frist dose of Diclofenac Na rectal supp100mg and then 12,24, 36 hour after surgery Diclofenac Na rectal supp50mg was done
Category
Treatment - Drugs
2
Description
Pentazosin Amp (30mg) if necessary
Tplidaro Factory
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadougi University of Medical Sciences
Full name of responsible person
Fatemeh Ezeddini Ardakani
Street address
Bahonar squ- Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadougi 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
Shahid Sadougi University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
MS
Other areas of specialty/work
Street address
Nursing & Midwiferry Collage- Yazd
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
mah_bokaie@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
MSc
Other areas of specialty/work
Street address
Bahonar squ- Yazd
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
Email
mah_bokaie@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadougi University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Yazd Shahid Sadougi University of Medical Sciences
City
Yazd
Postal code
Phone
Fax
Email
behnaz_enjezab@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)