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Bedside Sedation for the Prevention of Post Dural Puncture Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01503788
Recruitment Status : Unknown
Verified January 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 4, 2012
Last Update Posted : January 4, 2012
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Post Dural Puncture Headache Drug: Midazolam Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Periprocedural Sedation for the Prevention of Post Dural Puncture Headache
Study Start Date : February 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: periprocedural sedation with midazolam
periprocedural sedation with IV midazolam 5-10 minutes before diagnostic lumbar puncture
Drug: Midazolam
participants will be given Midazolam IV 10-5 minutes prior to diagnostic lumbar puncture

No Intervention: No intervention
Participants will undergo the diagnostic lumbar puncture as routinely practiced



Primary Outcome Measures :
  1. rate of post dural puncture headache [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503788


Contacts
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Contact: Haggai Sharon, MD 972-3-697-6979975 haggais@tasmc.health.gov.il

Locations
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Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Principal Investigator: Haggai Sharon, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01503788    
Other Study ID Numbers: TASMS-12-HS-0101-11-TLV-CTIL
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action