The aim of this study was be to assess the effects of entonox in compare with lidocaine on severity of pain during episiotomy incision and repair in nulliparous women. This randomized, single blind, comparison study was carried out in Alhadi Hospital, Shushtar, Iran. Inclusion criteria for this study included: primipara women between 39 to 42 weeks of gestation according to sonography findings or last menstrual period date; mother’s age in 18 to 35 years; singleton; nulliparous; cephalic presentation; first trimester body mass index in range of 19.8 to 30 Kilograms per square meter. Exclusion criteria: presence of systemic diseases; abruption; postpartum bleeding; sensitivity to local anesthesia or entonox. One hundred and twenty nulliparous women were randomized in two group to take entonox (n=60) or lidocaine 2% (n=60). Intervention group received entonox two minutes before starting episiotomy incision and then entonox cut after incision, again two minutes before starting episiotomy repair until the end of the procedure to reduce the pain. Control group as routine received 5 milliliter lidocaine 2% before starting episiotomy incision and repair. The procedure of incision and repairing episiotomy was performed by one midwife. The severity of pain was measured using visual analogue scale (VAS) after repair episiotomy in two group’s number each sample were recorded in a data management by another staff unaware from type of analgesia, and compared in both the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062222874N1
Registration date:2016-01-22, 1394/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Azam Honarmandpour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3622 9544
Email address
honarmandpour.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Research and Information Technology; Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-06-25, 1394/04/04
Expected recruitment end date
2015-09-19, 1394/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of entonox in comparison with lidocaine on severity of pain after episiotomy in nulliparous women
Public title
The effect of entonox on episiotomy pain in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: primi para women between 39 to 42 weeks of gestation according to sonography findings or last menstrual period date; mother’s age in 18 to 35 years; singleton; nulliparous; cephalic presentation; first trimester body mass index in range of 19.8 to 30 Kilograms per square meter. Exclusion criteria: presence of systemic diseases; abruption; post partume bleeding; sensitivity to local anesthesia or entonox).
Age
From 17 years old to 34 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, City University, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2015-04-05, 1394/01/16
Ethics committee reference number
IR.AJUMS.REC.1394.151
Health conditions studied
1
Description of health condition studied
The relation ship between entonox with episiotomy pain in nulliparous women
ICD-10 code
O70.1
ICD-10 code description
Perineal laceration during delivery
Primary outcomes
1
Description
Severity of pain incision episiotomy
Timepoint
After episiotomy repair
Method of measurement
Visual Analogue Scale
2
Description
Severity of pain repair episiotomy
Timepoint
After episiotomy repair
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Side effects such as dry mouth, dizziness, increased drowsiness, nausea
Timepoint
after episiotomy repair
Method of measurement
Ask the client
Intervention groups
1
Description
Intervention group received entonox two minutes before starting episiotomy incision and then entonox cut after incision, again two minutes before starting episiotomy repair until the end of the procedure to reduce the pain. The procedure of incision and repairing episiotomy was performed by one midwife. The severity of pain was measured using visual analogue scale (VAS) after repair episiotomy number each sample were recorded in a data management by another staff. Entonox was maintained at above 10 ˚C in 24 hour before utilizing. Women in intervention group inhaled entonox deeply and slowly as they were trained. Entonox mask was putted on face by mother to inhale repeatedly according to respiration model “deep inhale pausing slow exhale rest”. Women are free to using entonox whenever they would like.
Category
Treatment - Drugs
2
Description
Control group as routine received 5 milliliter lidocaine 2% before starting episiotomy incision and again before starting episiotomy repair. The procedure of incision and repairing episiotomy was performed by one midwife. The severity of pain was measured using visual analogue scale (VAS) after repair episiotomy number each sample were recorded in a data management by another staff.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alhadi Hospital
Full name of responsible person
Azam Honarmandpour
Street address
Faculty Of Medical Sciences Shushtar ,West, Rajai Street, Shushtar, Iran
City
Shushtar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid لavadifar
Street address
Ahvaz Jundishapur University of Medical Sciences, City University, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
PhD, Assistant professor of Reproductive Health Research Center, Ahvaz Jundishapur University of Me
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, City University, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
Email
Nahid javadifar_341@yahoo.com
Web page address
www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
PhD, Assistant professor of Reproductive Health Research Center, Ahvaz Jundishapur University of Me
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, City University, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
+98 61133333477
Email
Nahid javadifa_341@yahoo.com
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Azam Honarmandpour
Position
MSc Midwifery
Other areas of specialty/work
Street address
Faculty Of Medical Sciences Shushtar ,West, Rajai Street, Shushtar, Iran