Metamizole for postoperative pain therapy in 1177 children: A prospective, multicentre, observational, postauthorisation safety study

BACKGROUND: Due to possible serious adverse drug reactions (ADRs), the use of metamizole for postoperative pain therapy in children is a subject of debate. Safety studies with large sample sizes have not been published as yet. OBJECTIVE: The aim of this study was to evaluate the use of metamizole in children aged up to 6 years undergoing surgery with a particular focus on serious ADRs such as haemodynamic, anaphylactic or respiratory reactions and agranulocytosis. DESIGN: A multicentre, prospective, noninterventional, observational postauthorisation safety study (PASS). SETTING: The study was conducted in six different paediatric centres from September 2013 to September 2014. PATIENTS: One thousand one hundred and seventy-seven children aged up to six years (American Society of Anesthesiologists’ physical status class I to III) receiving a single dose of metamizole for postoperative pain therapy were enrolled. MAIN OUTCOME MEASURES: Patient demographics, main and secondary diagnoses, surgical procedures performed, metamizole dose, haemodynamic data, use of other analgesics and regional blocks, results of pain measurement (Children and Infants Postoperative Pain Scale, ChIPPS) and ADR incidence were documented using a standardised case report form. RESULTS: Of the 1177 children observed at six paediatric centres, 1145 were included for analysis [age 35.8 ± 18.1 (0.1 to 72) months]. The mean metamizole dose was 17.3 ± 2.9 (8.3 to 29.4) mg kg−1. Mean arterial press...
Source: European Journal of Anaesthesiology - Category: Anesthesiology Tags: Paediatric anaesthesia Source Type: research