The purpose of this study os to investigate the effect of intravenous Propofol on post-dural puncture headache . 40 patients with post dural puncture headache are enrolled. They are randomly divided into two groups. The control group receives conventional therapy including fluid and oral Acetaminophen while the intervention group will receive fluid and subanesthetic dose of intravenous propofol. They will receive rescue therapy with intravenous meperidine or epidural blood patch as needed. Pain score will be compared among these two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812083437N1
Registration date:2010-06-18, 1389/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-18, 1389/03/28
Registrant information
Name
Hedayatollah Elyassi
Name of organization / entity
Shaheed Beheshti University of Medical Sciences, Taleghani Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2572
Email address
a.r.c@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesiology Research Center
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous Propofol on post-dural puncture headache
Public title
Effect of intravenous Propofol on post-dural puncture headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from post-dural puncture headache, ASA class 1 and 2, not received intravenous therapy except fluid for their current headache, headache started within last 48 hours
Exclusion criteria: Patients with ASA classes other than 1 and 2, receiving intravenous treatment, drug addiction
Age
From 14 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shaheed Beheshti Medical University
Street address
Velenjak
City
Tehran
Postal code
Approval date
2010-03-19, 1388/12/28
Ethics committee reference number
00123
Health conditions studied
1
Description of health condition studied
postdural puncture headache
ICD-10 code
G97.1
ICD-10 code description
Other reaction to spinal and lumbar puncture
Primary outcomes
1
Description
pain
Timepoint
Every 5 minutes untill 24 hours
Method of measurement
VAS
Secondary outcomes
1
Description
opioid need
Timepoint
Every 5 minutes untill 24 hours
Method of measurement
mg of pethidine needed to reduce paine to less than 3 (VAS)
Intervention groups
1
Description
acetaminophen (500 mg oral every 4 hour for 24 hours)
Category
Treatment - Drugs
2
Description
propofol (1 mg/kg/h IV infusion for 30 minutes every 6 h till 24 hour)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Anesthesiology Research Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Hedayatollah Elyassi
Street address
Anesthesiology Research Center,Taleghani Hospital, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology Research Center
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
Anesthesiology Research Center
Full name of responsible person
Hedayatollah Elyassi
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology Research Center,Taleghani Hospital, Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 2572
Fax
Email
a.r.c@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Hedayatollah Elyassi
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology Research Center,Taleghani Hospital, Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 2572
Fax
Email
a.r.c@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Hedayatollah Elyassi
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology Research Center,Taleghani Hospital, Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 2572
Fax
Email
a.r.c@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)