Comparative evaluation of effect of IV Dexamethasone on post-cesarean pain
Introduction: operations lead to body stress and tissue injury that cause pain and many complications due to pain.
Purpose of this study is to evaluate the effect of IV administration of Dexamethasone on pain reduction after caesarean.
Methods and Materials :In a randomized double-blinded clinical trial we select 60 G1 women who are candidated for single elective caesarean at beheshti hospital and did not have any sensitivity or allergy to glucocorticoids; present or past history of PUD( peptic ulcer disease), glaucoma, DM( Diabete Mellitus ) 1,2, heart failure, fungal or viral systemic infection, HTN ( Hypertention ) or any other poor-controlled disease and divide them randomly into 2 groups (8 mg dexamethasone or2 cc normal salin recipient )and then we recorde variables such as MAP ( Mean Arterial blood Pressure, HR ( heart rate), RR ( respiratory rate ), pain and vomiting severity based on VAS ( Visual Analogue Scale ) and morphine and methoclopramide consumption and finally analyzed data by t test and ManWitney test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104095934N2
Registration date:2012-07-21, 1391/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-21, 1391/04/31
Registrant information
Name
Mahdi Babaei
Name of organization / entity
Isfahan University of Medical Sciences-Dentistry college
Country
Iran (Islamic Republic of)
Phone
+98 31 1788 3314
Email address
babaei@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2012-08-05, 1391/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effect of IV Dexamethasone on post-cesarean pain
Public title
Effect of dexamethasone on reduction of pain after cesarean section.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy pregnant, single baby and full term (G1) women who were candidated for elective cesarean in Beheshti hospital.
Exclusion criteria: any sensitivity or allergy to glucocorticoids; present or past history of PUD( peptic ulcer disease), glaucoma, DM( Diabete Mellitus ) 1,2, heart failure, fungal or viral systemic infection, HTN ( Hypertention ) or any other poor-controlled disease.
Age
From 18 years old to 34 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Scienses
Street address
Hezarjarib avenue-Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2009-05-24, 1388/03/03
Ethics committee reference number
388122
Health conditions studied
1
Description of health condition studied
Pain after celective cesarean
ICD-10 code
(O80-O84De
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Effect of IV Dexamethasone on post-cesarean pain
Timepoint
At at time of 0, 15, 30, 60 min and 2, 4, 6, 12, 18, 24 hours after CS
Method of measurement
Severity of pain and vomiting ( base on VAS) was measured by giving a 10cm ruler to the patients .VAS ( Visual Analogue Scale ) is a method of pain evaluation by using a 10cm.in this method, the patient will be asked to indicate zero in case of having no pain and ten in case of having the most sever pain
2
Description
Effect of IV dexamethasone on reduction of morphine consumption after cesarean section
Timepoint
All the patients receive one routine dose of morphine at recovery room and then if need with intervals of 4 hours. Morphin consomption rate is recorded and in the end will be evaluated.
Method of measurement
Results which are recorded based on miligrams
3
Description
Effect of IV Dexamethasone on reduction of vomiting and methoclopramide consumption after cesarean section
Timepoint
Monitored at time of 0, 15, 30, 60 min and 2, 4, 6, 12, 18, 24 hours after CS
Method of measurement
Severity of pain and vomiting ( base on VAS) is measured by giving a 10cm ruler to the patients .VAS ( Visual Analogue Scale ) is a method of pain and vomiting evaluation by using a 10cm.in this method, the patient will be asked to indicate zero in case of having no vomiting and ten in case of having the most sever vomiting. we considered VAS score 1-3 as mild,4-7 as moderate and 7-10 as sever.Rescue antiemetic (methoclopramide 10 mg, ) was given if vomiting occurrs or at parturientś request. treatment is repeated if necessary.and total dose of methoclopramide will be recorded
Secondary outcomes
1
Description
Effect of IV dexamethasone on vital sign ( MAP ( mean arterial pressure),HR ( heart rate ),RR( respiratory rate )
Timepoint
At times of 0, 15, 30, 60 min and 2, 4, 6, 12, 18, 24 hours after CS
Method of measurement
By using a sphigmomanometer for blood pressure and a digital watch for RR and HR
Intervention groups
1
Description
we administer 8 mg of IV dexamethasone to case group
Category
Treatment - Drugs
2
Description
the control group receive 2 cc normal saline at the same time
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital -the operation room
Full name of responsible person
dr Azar Danesh Shahraki-assistant professor
Street address
Isfahan-Beheshti Hospital-gynecology and obstetrics department
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, research unit
Full name of responsible person
Mr Moradi
Street address
research unit, faculty of medicine, Isfahan university of medical scienses, hezarjarib avenue, isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, research unit
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
Medicine college, Isfahan University of Medical Sciences