This randomized single-blind controlled trial was performed to compare the effectiveness of 2 analgesics for the management of perineal pain due to episiotomy. Methods: A total of 170 Nulli parous women who gave birth vaginally with episiotomy between March 2009 and November 2010 at a teaching hospital affiliated to ministry of health (shahid Mostafa Khomaini hospital, Ilam, Iran) were randomly assigned to receive either ibuprofen (400 mg) (n = 85) or Celecoxib (100mg) (n = 85), ibuprofen and Celecoxib given orally every 6 and 12 hours, respectively, as necessary. Inclusion criteria: 1- 18-35 years old; 2-mediolateral episiotomy; 3-singleton; 4- alive fetus. Exclusion criteria: 1-sensitivity to NSAIDs; 2-history of digestive system disorders; 3-presence of chronic illness; 4-rupture of cervix; 5-post partum hemorrhage; 6-pre eclampcia and eclampcia; 7-PROM. Pain ratings were measured before intervention and at 1, 2, 4, 8 and 12 hours after the first dose on a 10-cm visual analogue scale (in resting and moving stages).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106136790N1
Registration date:2012-08-14, 1391/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-14, 1391/05/24
Registrant information
Name
Zainab Suhrabi
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1222 7123
Email address
suhrabi-z@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology of Ilam University of Medical Sciences
Expected recruitment start date
2009-03-30, 1388/01/10
Expected recruitment end date
2010-10-29, 1389/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Ibuprofen and Celecoxib on the intensity of perineal pain following episiotomy: a single blind, randomized clinical trial
Public title
Comparing the efficacy of Ibuprofen and Celecoxib on the intensity of perineal pain following episiotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-18-35 y/o; 2-mediolateral episiotomy; 3-singleton; 4- alive fetus. Exclusion criteria: 1-sensitivity to NSAIDs; 2-history of digestive system disorders; 3-presence of chronic illness; 4-rupture of cervix; 5-post partum hemorrhage; 6-pre eclampcia and eclampcia; 7-PROM.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Banganjab, Pajohesh Blvd
City
Ilam
Postal code
Approval date
2008-10-11, 1387/07/20
Ethics committee reference number
5195/40/22
Health conditions studied
1
Description of health condition studied
post episiotomy pain
ICD-10 code
O75.4
ICD-10 code description
Other complications of obstetric surgery and procedures
Primary outcomes
1
Description
pain severity
Timepoint
pre intervention,1, 2, 4, 8 and 12 hours after intervention
Method of measurement
VAS
Secondary outcomes
1
Description
Digestive system complications
Timepoint
Every 12 hours
Method of measurement
History and Physical exam
Intervention groups
1
Description
Ibuprofen (400 mg), every 6 and 12 hours as necessary
Category
Treatment - Drugs
2
Description
Celecoxib (100mg), orally, 6 and 12 hours as necessary
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomaini hospital
Full name of responsible person
Street address
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Morvat Taheri Kalani
Street address
Banganjab, Pagohesh Blvd.
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Zainab Suhrabi
Position
MSc of Midwifry/ faculty member
Other areas of specialty/work
Street address
Banganjab,pajohesh BLvd.
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
+98 84 1222 7123
Email
suhrabi-z@medilam.ac.ir ; suhrabi2007@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Zainab Suhrabi
Position
MSc of Midwifry/ faculty member
Other areas of specialty/work
Street address
Banganjab, Pajohesh Blvd.
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
suhrabi-z@medilam.ac.ir ; suhrabi2007@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Zainab Suhrabi
Position
MSc of Midwifry
Other areas of specialty/work
Street address
Banganjab, Pajohesh Blvd.
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
suhrabi-z@medilam.ac.ir ; suhrabi2007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)