Bedside Sedation for the Prevention of Post Dural Puncture Headache
Primary Purpose
Post Dural Puncture Headache
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Post Dural Puncture Headache
Eligibility Criteria
Inclusion Criteria:
- 18-50 years old
- Undergoing diagnostic LP for any indication for the first time
Exclusion Criteria:
- COPD
- Any known chronic pulmonary disease
- Acute febrile illness
- Persistent headaches
- Known sensitivity to Benzodiazepines
- Current or prior substance abuse disorder
- Cognitive decline
Sites / Locations
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
periprocedural sedation with midazolam
No intervention
Arm Description
periprocedural sedation with IV midazolam 5-10 minutes before diagnostic lumbar puncture
Participants will undergo the diagnostic lumbar puncture as routinely practiced
Outcomes
Primary Outcome Measures
rate of post dural puncture headache
Secondary Outcome Measures
Full Information
NCT ID
NCT01503788
First Posted
January 1, 2012
Last Updated
January 3, 2012
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01503788
Brief Title
Bedside Sedation for the Prevention of Post Dural Puncture Headache
Official Title
Periprocedural Sedation for the Prevention of Post Dural Puncture Headache
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dural or lumbar puncture (LP), the passing of a needle into the space of the spinal cord, is a common procedure in everyday clinical practice. The most common use for LP is to measure the spinal fluid pressure and sample spinal fluid for laboratory analysis. However, it is also used for therapeutic purposes, such as administering chemotherapy or spinal anesthesia.
A notorious side effect of dural puncture is headache that ranges from mild to debilitating and may last for several days following the procedure. Among diagnosed patients, 39% experience at least 1 week of impaired ability to perform activities of daily living. The likelihood of developing a headache after dural puncture depends on a number of factors. As fluid leak is assumed to be the culprit mechanism in this headache strategies to minimize the leak seem to offer the best path to lowering the incidence of headache after diagnostic LP, the commonest clinical context of dural puncture in medical practice.
Lumbar puncture is a highly stressful event for most patients. As both pain and anxiety cause adrenergic stimulation, they also cause an increase in ICP. We believe that this mild increase in ICP, occurring before the puncture as well as during the puncture itself may exacerbate the pressure difference between the CSF space and the epidural space and so worsen the CSF leak Furthermore, this excess pressure, although mild, might cause the dural puncture hole to widen slightly and so further augment the leak and possibly even prolong it. Furthermore, the very anticipation of pain causes a rise in neurotransmitters that may cause a sensitization effect and worsen pain. This increase in adrenergic drive as well as the sensitization to pain can be effectively blunted by the periprocedural use of mild IV sedation. Benzodiazepines, with their sedative-hypnotic qualities are well suited for this task.
This study aims to test the effect of mild peri-procedural IV sedation using Midazolam on the rates of headache after diagnostic LP.
Patients undergoing a diagnostic LP will be randomized into two groups. Group 1 will undergo the procedure as routinely practiced. Group 2 will be given Midazolam IV 10-5 minutes prior to the procedure and undergo the same diagnostic procedure. All patients in the study will remain under observation in the hospital for at least 6 hours.
Patients will be evaluated for headache and specifically for headache. Clinical follow up will continue for 72 hours by administering a short questionnaire over the telephone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Dural Puncture Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
periprocedural sedation with midazolam
Arm Type
Active Comparator
Arm Description
periprocedural sedation with IV midazolam 5-10 minutes before diagnostic lumbar puncture
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants will undergo the diagnostic lumbar puncture as routinely practiced
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
participants will be given Midazolam IV 10-5 minutes prior to diagnostic lumbar puncture
Primary Outcome Measure Information:
Title
rate of post dural puncture headache
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-50 years old
Undergoing diagnostic LP for any indication for the first time
Exclusion Criteria:
COPD
Any known chronic pulmonary disease
Acute febrile illness
Persistent headaches
Known sensitivity to Benzodiazepines
Current or prior substance abuse disorder
Cognitive decline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haggai Sharon, MD
Phone
972-3-697-6979975
Email
haggais@tasmc.health.gov.il
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haggai Sharon, MD
12. IPD Sharing Statement
Learn more about this trial
Bedside Sedation for the Prevention of Post Dural Puncture Headache
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