The objective of this study is to determine the effect of Midazolam in in the severity of pain in Cesarean Section (C/S). The total sample size is 124 pregnant patients who will admit In Imam Reza Hospital, Kermanshah University of Medical Science will participate in this study. the patients will divided in two groups that included experimental group and the control group. Patients in the experimental group will received Bupivacaine plus intrathecal Midazolam. Bupivacaine plus normal saline will used in control group. The main outcome measure of pain is Verbal Numerical Rating Scale(VNRS) measured in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807121310N4
Registration date:2010-03-31, 1389/01/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-31, 1389/01/11
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2007-12-10, 1386/09/19
Expected recruitment end date
2009-12-10, 1388/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrathecal Midazolam in the severity of pain in Cesarean Section: A randomized controlled trial
Public title
The effect of intrathecal Midazolam in the severity of pain in Cesarean Section: A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: No presence of severe spinal lesion, No presence of abscess or infection of skin and soft tissue in the location of needle insertion, No presence of sever anxiety and restlessness, No presence of Central Nervous System lesion, No presence of peripheral nerve lesion, No presence of significant mental disorders or drug abuse, Age 18-45 year.
Exclusion criteria: severe spinal lesion, abscess or infection of skin and soft tissue in the location of needle insertion, sever anxiety and restlessness, Central Nervous System lesion, presence of peripheral nerve lesion, presence of significant mental disorders or drug abuse. Age less than 18 or more than 45 years old.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
124
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
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718818838
Approval date
2007-06-02, 1386/03/12
Ethics committee reference number
86118
Health conditions studied
1
Description of health condition studied
Pain in caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Severity of pain
Timepoint
5 min, 15 min, 30 min 1 hour, 2 hour and 4 hour aftercaesarean section
Method of measurement
Verbal Numerical Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group(62 patients) will received Bupivacaine (12.5 mg) plus intrathecal Midazolam (0.13 mg/kg) intratechally.
Category
Treatment - Drugs
2
Description
Bupivacaine (12.5 mg) plus normal saline (0.5-1 ml) will used in control group (62 patients),intratechally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Ali karbasfrushan
Street address
Imam reza Hospital.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Najafi
Street address
Deputy of Research, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Ali karbasfrushan, MD
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718818838
Phone
+98 918 137 0447
Fax
Email
ali_karbasfrushan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Imam Reza Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Ali karbasfrushan, MD
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718818838
Phone
+98 918 137 0447
Fax
Email
ali_karbasfrushan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Postal code
Phone
Fax
Email
ahmadiar1012@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)