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. 2023 Jun 24;23(1):321.
doi: 10.1186/s12887-023-04126-7.

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

Arnaud Schweitzer-Chaput  1 , Delphine Callot  1 , Naim Bouazza  2   3 , Fabrice Lesage  4 , Mehdi Oualha  2   4 , Nathalie Paret  5 , Marie Boyer-Gervoise  6 , Jean-Marc Treluyer  1   2   3 , Laurent Chouchana  7   8
Affiliations

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

Arnaud Schweitzer-Chaput et al. BMC Pediatr. .

Abstract

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

Methods: Spontaneous 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).

Results: Among 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.

Conclusion: In 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.

Keywords: Adverse drug reaction; Local anesthetics; Pediatric; Pharmacovigilance; Systemic toxicity.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of local anesthetics systemic toxicity cases included in the study
Fig. 2
Fig. 2
Adverse drug reaction pattern of local anesthetics systemic toxicity cases in children
See this image and copyright information in PMC

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