The aim of this study was to evaluate the effect of midazolam on decreasing incidence of post-dural puncture headache and decreasing the severity of post-dural puncture headache and reducing its duration.
Design
This study was a single blind randomized controlled clinical trial on 120 patients aged 18-60 years who were candidates for diagnostic dural puncture.
Settings and conduct
This study was done on a single blind randomized controlled clinical trial on 120 patients aged 18-60 years who were candidates for diagnostic lumbar puncture referred to Ahvaz Golestan Hospital. Patients were divided into two equal groups of intervention and control (number = 60) by block randomization and they had no awarness of grouping way. 5 minutes before lumbar puncture the intervention group had received 3 milligram Intravenous midazolam and the control group also received normal saline as placebo. Both groups were anesthetized with lidocaine and lumbar puncture was performed with Quincke needle 20 gauge in sterile and supine position. They were evaluated for incidence, onset, severity, and duration of headache. The severity of headache was measured using the visual analog scale.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
18-60 years old
Undergoing diagnostic LP for any indication
Exclusion Criteria:
Any known chronic pulmonary disease
Known sensitivity to Benzodiazepines
Decreased level of consciousness or other conditions that the patient is unable to tell us about his headache.
pregnancy
Intervention groups
Intervention group: receiving intravenous midazolam
Control group: receiving normal saline
Main outcome variables
1. Rate of post dural puncture headache
2. Severity of post dural puncture headache
3. Duration of post dural puncture headache
4. Onset of post dural puncture headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038631N1
Registration date:2019-09-29, 1398/07/07
Registration timing:retrospective
Last update:2019-09-29, 1398/07/07
Update count:0
Registration date
2019-09-29, 1398/07/07
Registrant information
Name
Mansoure Babadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3012
Email address
babadi.mansoureh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-20, 1397/02/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-05-20, 1397/02/30
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-02-23, 1397/12/04
Scientific title
The effect of midazolam on prevention of post dural puncture headache
Public title
The effect of midazolam on headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing diagnostic lumbar puncture for any indication
18 to 60 years old
Exclusion criteria:
Any known chronic pulmonary disease
Known sensitivity to benzodiazepines
Decreased level of consciousness or other conditions that the patient is unable to tell us about his headache.
Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method was used for randomization. Thirty blocks were created by www.randomizer.org. The blocks were the same size and equal to 4. In each block, there were two allocations for the intervention group and two allocations for the control one. In each block, 1 and 2 numbers were given in different order, which determined the group of patients. Number one was considered as intervention group and number two was used as control group. Patients were randomly assigned to intervention or control groups after being nominated for lumbar puncture on the basis of one and two numbers in blocks.Also the random sequence of blocks was in the hands of an individual other than the researcher who, by telephone, provided only the required number indicating the intervention or control group. Without researchers intervention, the patients were assigned to each groups based on numbers. After sampling accomplisehed, each groups had the same size with number of 60.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the patients in this study knew that they were in the intervention or control group and that the treatment received was either drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Development Research and Technology, Ahwaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.AJUMS.REC.1397.138
Health conditions studied
1
Description of health condition studied
Post dural puncture headache
ICD-10 code
G97.1
ICD-10 code description
Other reaction to spinal and lumbar puncture
Primary outcomes
1
Description
Incidence of post dural puncture headache
Timepoint
This evaluation was performed at 6, 12, 24, 48, 72 and on the fourth and fifth days after lumbar puncture.
Method of measurement
Diagnostic criteria of the International Classification of Headache Disorders, third edition (beta version)
2
Description
The severity of post dural puncture headache
Timepoint
This evaluation was performed at 6, 12, 24, 48, 72 and on the fourth and fifth days after lumbar puncture.
Method of measurement
Visual Analogue Scale
3
Description
The duration of post dural puncture headache
Timepoint
This evaluation was performed at 6, 12, 24, 48, 72 and on the fourth and fifth days after lumbar puncture.
Method of measurement
Daily headache diary
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 milligram midazolam diluted in normal saline and volume of 5 milliliter was injected intravenously five minutes before dural puncture in single dose.
Category
Treatment - Drugs
2
Description
Control group: Only 5 milliliter normal saline was injected intravenously five minutes before dural puncture in single dose.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Mansoureh Babadi
Street address
Department of Neurology, Golestan Hospital, Farvardin St., Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
babadi.mansoureh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Development Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin St., Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Fax
Email
dakashi47@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin St., Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Fax
Email
dakashi47@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mansoureh Babadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin St., Golestan, ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Fax
Email
babadi.mansoureh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available