Comparitive prophylactic effect of pregabalin versus aminophylline plus dexamethasone in preventing postdural puncture headache in caesarian delivery.A double blind clinical trial.
Summary : The aim of this study is to compare prophylactic effect of pregabalin versus aminophylline plus dexamethasone in preventing postdural puncture headache in caesarian delivery. Inclusion criteria are elective cesarian and age between 18 -45. Exclusion criteria are history of sensitivity to medication; chronic headace and any condition that contraindicate spinal anesthesia.In a double blind randomized clinical trail 300 patients will be divided to three equals group(n=100) All the patients in control group receive placebo(oral capsule like pregabelin and intravenous salin as aminophylline plus dexamethasone) . In two case groups all the patients receive prophylactic pregabalin(60 mg) after dilivery of fetus or aminophylline plus dexamethasone .Headace , need to analgesic drugs, patient satisfaction and time of discharge will be recorded and analyzed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601161936N16
Registration date:2016-02-22, 1394/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-22, 1394/12/03
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-04-01, 1394/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparitive prophylactic effect of pregabalin versus aminophylline plus dexamethasone in preventing postdural puncture headache in caesarian delivery.A double blind clinical trial.
Public title
Comparitive prophylactic effect of pregabalin versus aminophylline plus dexamethasone in preventing postdural puncture headache in caesarian delivery.A double blind clinical trial.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients who are candidates for elective cesarian and age between 18 -45. Exclusion criteria: history of sensitivity to medication; chronic headace and any condition that contraindicate spinal anesthesia.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences -Siraf Street
City
Bushehr
Postal code
Approval date
2015-07-20, 1394/04/29
Ethics committee reference number
BPUMS/REC.11394.13
Health conditions studied
1
Description of health condition studied
prophylactic effect of pregabalin versus aminophylline plus dexamethasone in preventing postdural puncture headache
ICD-10 code
M79.9
ICD-10 code description
Soft tissue disorder, unspecified
Primary outcomes
1
Description
Post spinal headace
Timepoint
Two weeks
Method of measurement
Question
Secondary outcomes
1
Description
Patient satisfication
Timepoint
Two weeks
Method of measurement
Question
Intervention groups
1
Description
Group C received saline (placebo) i.v in similar volume of dexamethasone plus aminophylline and the oral placebo capsule 3 times a day
Category
Treatment - Drugs
2
Description
Group P(pregabaline ) receive 100mg oral pregabaline capsule 3 times a day (each 8 hour) before onset of headache and saline i.v. in similar volume of dexamethasone plus aminophylline as placebo for blinding the study
Category
Treatment - Drugs
3
Description
Group A(aminophylline plus dexamethasone) receive aminophylline 1.5 mg/kg i.v. plus dexamethasone 0.1 mg/kg i.v and a placebo oral capsule similar in shape to the pregabaline 3 times a day thirty minutes after umbilical cord clamping.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye khalig fars Hospital
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Street address
Bushehr University of Medical Sciences ,Siraf
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Majid Asadi
Street address
Bushehr University of Medical Sciences، Siraf
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associate Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences ، Siraf Street
City
Bushehr
Postal code
Phone
+98 77 3354 0088
Fax
Email
arna566@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associate Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences ، Siraf Street
City
Bushehr
Postal code
Phone
+98 77 3354 0088
Fax
Email
arna566@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Associate Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences ، Siraf Street
City
Bushehr
Postal code
Phone
+98 77 3354 0088
Fax
Email
arna566@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)