Post Dural Puncture Headache Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate of post dural puncture headache | 72 hours | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01448590 -
Post Dural Puncture Headache After Accidental Dural Puncture
|
N/A | |
| Completed |
NCT00809627 -
Caffeine Versus Placebo for Spinal Headaches
|
N/A |