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

Melanie Fieler1, Christoph Eich, Karin Becke

  • 1From the Clinic for Anaesthesiology and Intensive Care Medicine, Hanover Medical School (MF, RS), Department of Anaesthesia, Paediatric Intensive Care and Emergency Medicine, Auf der Bult Children[Combining Acute Accent]s Hospital, Hanover (CE), Department of Anaesthesiology and Intensive Care Medicine, Cnopf[Combining Acute Accent]sche Kinderklinik/Klinik Hallerwiese, Nuremberg (KB), Department of Anaesthesiology and Paediatric Anaesthesiology, Krankenhaus Barmherzige Brüder Regensburg/Klinik St. Hedwig, Regensburg (GB), Department of Anaesthesiology, Intensive Care and Emergency Medicine, Protestant Hospital Bielefeld, Bielefeld (KL), Department of Anaesthesiology, Intensive-Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt am Main (LM), and Clinic for Cardiac, Thoracic, Transplant and Vascular Surgery, Hanover Medical School, Hanover, Germany (DB).

European Journal of Anaesthesiology
|June 19, 2015
PubMed

Insights

Metamizole is safe for postoperative pain in children under six, with serious adverse drug reactions (ADRs) occurring in less than 0.3%. Further studies are needed to assess agranulocytosis risk.

Area of Science:

  • Pediatric Anesthesiology
  • Pharmacovigilance
  • Pain Management

Background:

  • Metamizole use in pediatric postoperative pain management is debated due to potential serious adverse drug reactions (ADRs).
  • Limited large-scale safety data exists for metamizole in pediatric populations.

Purpose of the Study:

  • To evaluate the safety and efficacy of metamizole for postoperative pain in children up to 6 years old.
  • To specifically assess serious ADRs, including hemodynamic, anaphylactic, respiratory reactions, and agranulocytosis.

Main Methods:

  • A prospective, multicenter, observational post-authorization safety study (PASS) involving 1145 children aged 0-6 years.
  • Data collected included patient demographics, surgical procedures, metamizole dosage, hemodynamic parameters, pain scores (ChIPPS), and ADR incidence.
  • Standardized case report forms were used across six pediatric centers over a 12-month period.

Main Results:

  • Single intravenous metamizole doses were well-tolerated in 1145 children.
  • Mean arterial pressure remained stable post-administration (P < 0.01).
  • Minor ADRs (pruritus, swelling, exanthema) occurred in 0.3% of patients; no respiratory events or signs of agranulocytosis were reported.

Conclusions:

  • Single intravenous doses of metamizole are well-tolerated for pediatric postoperative pain in children up to 6 years.
  • The observed incidence of serious ADRs (hemodynamic, anaphylactic, respiratory) is below 0.3%.
  • The study's sample size and follow-up duration were insufficient to rule out agranulocytosis episodes.
Abstract

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