Bedside Sedation for the Prevention of Post Dural Puncture Headache

NCT01503788 | Unknown Phase 2

• 1 other identifier: TASMS-12-HS-0101-11-TLV-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• rate of post dural puncture headache

  72 hours

Study Arms (2)

periprocedural sedation with midazolam

ACTIVE COMPARATOR

periprocedural sedation with IV midazolam 5-10 minutes before diagnostic lumbar puncture

Drug: Midazolam

No intervention

NO INTERVENTION

Participants will undergo the diagnostic lumbar puncture as routinely practiced

Interventions

Midazolam DRUG

participants will be given Midazolam IV 10-5 minutes prior to diagnostic lumbar puncture

periprocedural sedation with midazolam

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Undergoing diagnostic LP for any indication for the first time

You may not qualify if:

• COPD
• Any known chronic pulmonary disease
• Acute febrile illness
• Persistent headaches
• Known sensitivity to Benzodiazepines
• Current or prior substance abuse disorder
• Cognitive decline

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Haggai Sharon, MD

CONTACT

972-3-697-6979975; haggais@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2012
• First Posted: January 4, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 4, 2012

Record last verified: 2012-01

Locations

IL (1)