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Post lumbar puncture headache: Case report of a serious adverse event in first-in-human study.

ABSTRACT: A lumbar puncture can be used to measure the concentrations of drugs and/or pharmacodynamic biomarkers during clinical trials of central nervous system drugs. We report a case of a post lumbar puncture headache (PLPH) in a first-in-human study, which was reported as a serious adverse event. A 20-year-old man received 200 mg of the investigational product (IP) for 7 days and underwent a lumbar puncture for cerebrospinal fluid sampling before IP administration (Day 1, pre-dose) and after 7 days and multiple IP administrations (Day 7, 1 hour post-dose). After discharge on Day 8, the subject complained of headache, nausea, vomiting, neck stiffness, and numbness of the extremities. The symptoms occurred when he got up and disappeared after he remained in the supine position for several minutes. Five days later, he visited the neurology clinic of the main hospital. The neurologist recommended hospitalization for further evaluation and symptom management, and the subject was then admitted to the hospital. There were no abnormal findings in vital signs, laboratory results, or brain-computed tomography. His symptoms disappeared during the hospitalization period. It was important to distinguish whether the headache was IP-related or lumbar puncture-related. Therefore, knowledge of clinical characteristics and differential diagnosis of PLPH is paramount. Furthermore, if severe PLPH occurs, a consultation with a neurologist and imaging studies should be considered for a differential diagnosis of PLPH.

SUBMITTER: Shin W

PROVIDER: S-EPMC7033405 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Post lumbar puncture headache: Case report of a serious adverse event in first-in-human study.

Shin Wonsuk W Kim Min-Kyoung MK Kim Jinkwon J Woo Min-Hee MH Cho Doo-Yeon DY Lim Kyoung Soo KS

Translational and clinical pharmacology 20171220 4

A lumbar puncture can be used to measure the concentrations of drugs and/or pharmacodynamic biomarkers during clinical trials of central nervous system drugs. We report a case of a post lumbar puncture headache (PLPH) in a first-in-human study, which was reported as a serious adverse event. A 20-year-old man received 200 mg of the investigational product (IP) for 7 days and underwent a lumbar puncture for cerebrospinal fluid sampling before IP administration (Day 1, pre-dose) and after 7 days an ...[more]

PMID: 32095469

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Project description:BackgroundHeadache is disabling and prevalent in idiopathic intracranial hypertension. Therapeutic lumbar punctures may be considered to manage headache. This study evaluated the acute effect of lumbar punctures on headache severity. Additionally, the effect of lumbar puncture pressure on post-lumbar puncture headache was evaluated.MethodsActive idiopathic intracranial hypertension patients were prospectively recruited to a cohort study, lumbar puncture pressure and papilloedema grade were noted. Headache severity was recorded using a numeric rating scale (NRS) 0-10, pre-lumbar puncture and following lumbar puncture at 1, 4 and 6 hours and daily for 7 days.ResultsFifty two patients were recruited (mean lumbar puncture opening pressure 32 (28-37 cmCSF). At any point in the week post-lumbar puncture, headache severity improved in 71% (but a small reduction of -1.1?±?2.6 numeric rating scale) and exacerbated in 64%, with 30% experiencing a severe exacerbation???4 numeric rating scale. Therapeutic lumbar punctures are typically considered in idiopathic intracranial hypertension patients with severe headaches (numeric rating scale???7). In this cohort, the likelihood of improvement was 92% (a modest reduction of headache pain by -3.0?±?2.8 numeric rating scale, p?=?0.012, day 7), while 33% deteriorated. Idiopathic intracranial hypertension patients with mild (numeric rating scale 1-3) or no headache (on the day of lumbar puncture, prior to lumbar puncture) had a high risk of post- lumbar puncture headache exacerbation (81% and 67% respectively). Importantly, there was no relationship between lumbar puncture opening pressure and headache response after lumbar puncture.ConclusionFollowing lumbar puncture, the majority of idiopathic intracranial hypertension patients experience some improvement, but the benefit is small and post-lumbar puncture headache exacerbation is common, and in some prolonged and severe. Lumbar puncture pressure does not influence the post-lumbar puncture headache.

Project description:Importance:Women giving birth have high rates of dural puncture secondary to neuraxial anesthesia and are at high risk for a resulting headache. It appears to be unknown whether there is a significant association between post-dural puncture headache and subsequent intracranial subdural hematoma. Objective:To determine the association of post-dural puncture headache with postpartum intracranial subdural hematoma. Design, Setting, and Participants:This cohort study of patients used hospital discharges recorded in the US Agency for Healthcare Research and Quality National Readmission Database for women who experienced childbirth from January 2010 to December 2016. Patients were included if they had been admitted for childbirth, had 2 months of follow-up data, and did not receive a diagnostic lumbar puncture. Only the first delivery for a calendar year was studied. Data were analyzed from January 2018 to June 2019. Exposures:Women with post-dural puncture headache associated with neuraxial anesthesia in the 2-month postpartum period were identified using International Classification of Disease (Ninth Edition and Tenth Edition) codes and were compared with those without post-dural puncture headaches. Main Outcome and Measures:The primary outcome was intracranial subdural hematoma in the 2-month postpartum period. Secondary outcomes included in-hospital mortality and occurrence of neurosurgery. Results:A total of 26?469?771 patients with 26?498?194 deliveries were included. Exclusion of repeated deliveries (n?=?28?423), deliveries without 2 months of follow-up data (n?=?4?329?621), and deliveries with diagnostic lumbar puncture (n?=?9334) resulted in a final cohort of 22?130?815 patients and deliveries. For the cohort, the mean (SD) age was 28.1 (6.0) years, and there were 68?374 post-dural puncture headaches, for an overall rate of 309 (95% CI, 302-316) per 100?000. There were 342 cases of subdural hematoma identified, indicating a rate of 1.5 (95% CI, 1.3-1.8) per 100?000 women. Of these, 100 cases were in women with post-dural puncture headache, indicating a rate of 147 (95% CI, 111-194) hematoma cases per 100?000 deliveries in this subgroup. Post-dural puncture headache had an unadjusted absolute risk increase of 145 (95% CI, 117-174) subdural hematoma cases per 100?000 deliveries. After adjusting for confounders, post-dural puncture headache had an odds ratio for subdural hematoma of 199 (95% CI, 126-317; P?<?.001) and an adjusted absolute risk increase of 130 (95% CI, 90-169; P?<?.001) per 100?000 deliveries. Conclusions and Relevance:The presence of presumed post-dural puncture headache after neuraxial anesthesia in childbirth, compared with no headache, was associated with a small but statistically significant absolute increase in the risk of being diagnosed with intracranial subdural hematoma. Further research is needed to establish if this association is causal for this rare outcome.

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Post lumbar puncture headache: Case report of a serious adverse event in first-in-human study.

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Post lumbar puncture headache: Case report of a serious adverse event in first-in-human study.

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