Bedside Sedation for the Prevention of Post Dural Puncture Headache

Periprocedural Sedation for the Prevention of Post Dural Puncture Headache

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.

Study Overview

• Status: Unknown
• Conditions: Post Dural Puncture Headache
• Intervention / Treatment: Drug: Midazolam

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haggai Sharon, MD; Phone Number: 972-3-697-6979975; Email: haggais@tasmc.health.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
    • Principal Investigator: Haggai Sharon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of post dural puncture headache	72 hours

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ANTICIPATED): February 1, 2014
• Study Completion (ANTICIPATED): February 1, 2014

Study Registration Dates

• First Submitted: January 1, 2012
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (ESTIMATE): January 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 4, 2012
• Last Update Submitted That Met QC Criteria: January 3, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: TASMS-12-HS-0101-11-TLV-CTIL