search
Back to results

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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Dural Puncture Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 1, 2012
Last Updated
January 3, 2012
Sponsor
Tel-Aviv Sourasky Medical Center
search

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

We'll reach out to this number within 24 hrs