Evidence map›Paper›PMID 37355586›Full record

ArticleBMC pediatrics2023

Local anesthetics systemic toxicity in children: analysis of the French pharmacovigilance database.

Arnaud Schweitzer-Chaput, Delphine Callot, Naim Bouazza, Fabrice Lesage, Mehdi Oualha, Nathalie Paret, Marie Boyer-Gervoise, Jean-Marc Treluyer, Laurent Chouchana

Open access · goldAbstract read
In one paragraph

Article in BMC pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
5.2field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Arnaud Schweitzer-ChaputCentre Régional de Pharmacovigilance, Service de Pharmacologie, Hôpital Cochin, AP-HP, Paris, France.
Delphine CallotCentre Régional de Pharmacovigilance, Service de Pharmacologie, Hôpital Cochin, AP-HP, Paris, France.
Naim BouazzaPharmacologie Et Évaluation Des Thérapeutiques Chez L'enfant Et La Femme Enceinte (EA 7323), Université de Paris, Paris, France.
Fabrice LesageService de Réanimation Pédiatrique, Hôpital Necker, Paris, France.
Mehdi OualhaPharmacologie Et Évaluation Des Thérapeutiques Chez L'enfant Et La Femme Enceinte (EA 7323), Université de Paris, Paris, France.
Nathalie ParetCentre Antipoison, Hospices Civils De Lyon, Lyon, France.
Marie Boyer-GervoiseCentre Régional de Pharmacovigilance, Service de Pharmacologie Clinique, Assistance Publique Hôpitaux de Marseille, Marseille, France.
Jean-Marc TreluyerCentre Régional de Pharmacovigilance, Service de Pharmacologie, Hôpital Cochin, AP-HP, Paris, France.
Laurent ChouchanaCentre Régional de Pharmacovigilance, Service de Pharmacologie, Hôpital Cochin, AP-HP, Paris, France. laurent.chouchana@aphp.fr.
Assistance Publique – Hôpitaux de Paris · FRHôpital Cochin · FRAssistance Publique Hôpitaux de Marseille · FRHôpital Necker-Enfants Malades · FRHospices Civils de Lyon · FRLaboratoire de Psychologie du Développement et de L’Education de l’enfant · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo characterize clinical profile of pediatric local anesthetic (LA) systemic toxicity (LAST) and to identify determinants of life-threatening outcomes.

methodsSpontaneous reports notified to the French Pharmacovigilance Network were retrieved and followed by a case-by-case review, according to the following criteria: LA as suspected drug, age < 18 years, adverse drug reactions related to nervous system, cardiac, respiratory, psychiatric or general disorders. Multivariate logistic regression analysis was performed to identify factors leading to life-threatening reaction (i.e. continuous seizures or cardiorespiratory arrest).

resultsAmong 512 cases retrieved, 64 LAST cases were included (neonates 11%, infants 30%, children 36%, adolescents 23%) mainly involving lidocaine (47%), lidocaine + prilocaine (22%) and ropivacaine (14%). Toxicity profiles were neurological (58%), cardiac (11%) or mixed (20%) and 7 patients (11%) developed methemoglobinemia. LAST was life-threatening for 23 patients (36%) and 2 patients died. Doses were above recommendations in 26 patients (41%) and were not different between life-threatening and non-life-threatening cases. The context of use (general and orthopedic surgery, p = 0.006) and the type of LA agent (lidocaine, p = 0.016) were independently associated with a life-threatening outcome.

conclusionIn this national retrospective analysis, LAST in children appear to be a rare event. Neurological and cardiac signs were the most frequently reported reactions. LAST in children can be life-threatening, even at therapeutic doses. Although a fatal outcome may anecdotally occur, the vast majority of patients recovered after appropriate medical care.

Indexed as

Anesthetics, LocalPharmacovigilanceAdolescentChildHumansInfantInfant, NewbornLidocaineLidocaine, Prilocaine Drug CombinationRetrospective StudiesRopivacaineAnesthetics, LocalLidocaineLidocaine, Prilocaine Drug CombinationRopivacaineAdverse drug reactionLocal anestheticsPediatricPharmacovigilanceSystemic toxicity

Identifiers

PMID37355586
PMCPMC10290397
OpenAlexW4381943539

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.