A protocol to reduce self-reported pain scores and adverse events following lumbar punctures in older adults.
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ABSTRACT: Objective
Lumbar punctures (LPs) are important for obtaining CSF in neurology studies but are associated with adverse events and feared by many patients. We determined adverse event rates and pain scores in patients prospectively enrolled in two cohort studies who underwent LPs using a standardized protocol and 25 g needle.Methods
Eight hundred and nine LPs performed in 262 patients age ≥ 60 years in the MADCO-PC and INTUIT studies were analyzed. Medical records were monitored for LP-related adverse events, and patients were queried about subjective complaints. We analyzed adverse event rates, including headaches and pain scores.Results
There were 22 adverse events among 809 LPs performed, a rate of 2.72% (95% CI 1.71-4.09%). Patient hospital stay did not increase due to adverse events. Four patients (0.49%) developed a post-lumbar puncture headache (PLPH). Twelve patients (1.48%) developed nausea, vasovagal responses, or headaches that did not meet PLPH criteria. Six patients (0.74%) reported lower back pain at the LP site not associated with muscular weakness or paresthesia. The median pain score was 1 [0, 3]; the mode was 0 out of 10.Conclusions
The LP protocol described herein may reduce adverse event rates and improve patient comfort in future studies.
SUBMITTER: Nobuhara CK
PROVIDER: S-EPMC7336280 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundCore cerebrospinal fluid (CSF) amyloid and tau biomarker assessment has been recommended to refine the diagnostic accuracy of Alzheimer's disease. Lumbar punctures (LP) are invasive procedures that might induce anxiety and pain. The use of non-pharmacological techniques must be considered to reduce the patient's discomfort, in this setting. The objective of this study was to examine the efficacy of hypnosis on anxiety and pain associated with LP.MethodsA monocentric interventional randomized-controlled pilot study is conducted in a university geriatric day hospital. Cognitively impaired patients aged over 70 were referred for scheduled LP for the diagnostic purpose (CSF biomarkers). The participants were randomly assigned either to a hypnosis intervention group or usual care. Pain and anxiety were both self-assessed by the patient and hetero-evaluated by the operator.ResultsWe included 50 cognitively impaired elderly outpatients (women 54%, mean age 77.2 ± 5.0, mean Mini-Mental State Examination score 23.2 ± 3.5). Hypnosis was significantly associated with reduced self-assessed (p < 0.05) and hetero-assessed anxiety (p < 0.01). Hetero-evaluated pain was significantly lower in the hypnosis group (p < 0.05). The overall perception of hypnosis was safe, well-accepted, and feasible in all the participants of the intervention group with 68% perceiving the procedure as better or much better than expected.ConclusionsThis pilot study suggested that hypnosis was feasible and may be used to reduce the symptoms of discomfort due to invasive procedures in older cognitively impaired patients. Our results also confirmed the overall good acceptance of LP in this population, despite the usual negative perception.Trial registrationClinicalTrials.gov NCT04368572. Registered on April 30, 2020.
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Project description:IntroductionThe rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown.MethodsThe primary objective of this study was to describe the profile of spontaneously reported AEFIs following COVID-19 vaccination in the Netherlands, including the primary and booster series. Reports from consumers and healthcare professionals were collected via a COVID-19 vaccine-tailored online reporting form by the National Pharmacovigilance Centre Lareb (Lareb) between 6 January 2021 and 31 August 2022. The data were used to describe the most frequently reported AEFIs per vaccination moment, the consumer experienced burden per AEFI, and differences in AEFIs reported for homologous and heterologous vaccination sequences.ResultsLareb received 227,884 spontaneous reports over a period of twenty months. Overall, a high degree of similarity in local and systemic AEFIs per vaccination moment was observed, with no apparent change in the number of reports of serious adverse events after multiple COVID-19 vaccinations. No differences in the pattern of reported AEFIs per vaccination sequence was observed.ConclusionSpontaneous reported AEFIs demonstrated a similar reporting pattern for homologous and heterologous primary and booster series of COVID-19 vaccination in the Netherlands.
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Project description:IntroductionThe rapid rollout of coronavirus disease 2019 (COVID-19) vaccines for a large proportion of the population necessitates a strong emphasis on safety. Complementary to the existing spontaneous reporting system, The Netherlands Pharmacovigilance Centre Lareb conducted patient-reported cohort event monitoring (CEM).ObjectiveThe primary aim was to investigate differences in the frequencies of any and commonly reported, 'well-known', systemic adverse events following immunization (AEFIs) with four COVID-19 vaccines (Pfizer's Comirnaty®, Moderna's Spikevax®, AstraZeneca's Vaxzevria® and the Janssen vaccine). As a secondary aim, we analyzed the frequencies of well-known systemic adverse events after the first and, if applicable, second COVID-19 vaccinations, taking into account age, sex and prior COVID-19 infection.MethodsPatient-reported outcomes (PROs) in the Netherlands starting in February 2021 were analyzed using a prospective cohort design.ResultsData of 27,554 participants who received one vaccination and 20,682 participants who received complete immunization were analyzed. The percentage of patients reporting any AEFI was high and ranged from approximately 53% for the Pfizer vaccine to approximately 94% for the Moderna vaccine. The frequency of serious AEFIs was low, with the highest frequency found for the AstraZeneca vaccine (0.228%). AEFIs were most often experienced by participants receiving the first dose of the AstraZeneca and Janssen vaccines and the second dose of the Moderna vaccine; the Pfizer vaccine was associated with the lowest rate of AEFIs. Participants with a COVID-19 history before vaccination experienced commonly reported systemic AEFIs more frequently after the first vaccination than after the second vaccination. Women and young people experienced more AEFIs than men and older people, respectively.ConclusionsThe analysis of a large cohort provides important information about the rates of AEFIs across age groups, among brands of vaccines and between those with and without prior COVID-19 infection. Participants reported a high number of AEFIs in general, but the frequency of serious AEFIs was low.
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Project description:BackgroundLimited data exist on the safety of the measles, mumps, and rubella (MMR) vaccine in adults. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in this previously understudied group.MethodsVAERS is the national spontaneous vaccine safety surveillance system coadministered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adults aged ≥19 years who received the MMR vaccine from 1 January 2003 to 31 July 2013. We clinically reviewed reports and available medical records for serious AEs, pregnancy reports, and reports for selected prespecified outcomes.ResultsDuring this period, VAERS received 3175 US reports after MMR vaccine in adults. Of these, 168 (5%) were classified as serious, including 7 reports of death. Females accounted for 77% of reports. The most common signs and symptoms for all reports were pyrexia (19%), rash (17%), pain (13%), and arthralgia (13%). We did not detect any new safety findings in empirical Bayesian data mining. We identified 131 reports of MMR vaccine administered to a pregnant woman; the majority of these vaccinations were in the first trimester and in 83 (62%), no AE was reported.ConclusionsIn our review of VAERS data, we did not detect any new or unexpected safety concerns for MMR vaccination in adults. We identified reports of pregnant women exposed to MMR, which is a group in whom the vaccine is contraindicated, suggesting the need for continued provider education on vaccine recommendations and screening.
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