Sümpelmann Robert, Fieler Melanie, Eich Christoph, Becke Karin, Badelt Gregor, Leimkühler Klaus, Dennhardt Nils
Clinic for Anesthesiology and Intensive Care Medicine, Hannover Medical School, Hannover, Germany.
Department of Anesthesia, Pediatric Intensive Care and Emergency Medicine, Auf der Bult Children's Hospital, Hannover, Germany.
Eur J Pediatr Surg. 2017 Jun;27(3):269-273. doi: 10.1055/s-0036-1587332. Epub 2016 Sep 5.
Due to possible serious adverse drug reactions (ADRs), the use of metamizole for postoperative pain therapy in infants is a subject of debate. Safety studies with large sample sizes are missing. This prospective multicenter observational study was conducted to evaluate the use of metamizole in infants younger than 1 year undergoing surgery with a particular focus on possible serious ADRs (e.g., hemodynamic, anaphylactic or respiratory reactions, and agranulocytosis). Infants aged up to 1 year (American Society of Anesthesiologists [ASA] I-III) receiving a single dose of metamizole for postoperative pain therapy were enrolled. Patient demographics, main and secondary diagnosis, surgical procedures performed, metamizole dose, hemodynamic data, use of other analgesics and regional blocks, results of pain measurement, and incidence of ADRs were documented using a standardized case report form. A total of 316 infants observed at five pediatric centers were included for analysis (age 4.4 ± 3.7 [0.06-12] months). Mean metamizole dose was 17.8 ± 3.1 (9.2-29.8) mg·kg. Mean arterial pressure (MAP) remained stable during metamizole infusion (MAP before infusion 45 ± 9.5 [25-95] and after infusion 45 ± 9.2 [25-99] mm Hg). Erythema was observed in one patient (ADRs total: 0.3%, 95% confidence interval: 0.27-0.32). No respiratory adverse events directly related to the metamizole administration and no clinical signs of agranulocytosis were reported. Single intravenous doses of metamizole used for prevention or treatment of postoperative pain were safe in more than 300 infants younger than 1 year. The statistical probability of serious ADRs (e.g., hemodynamic, anaphylactic or respiratory reactions) was lower than 1%. The sample size and follow-up were not sufficient to detect agranulocytosis.
由于可能出现严重的药物不良反应（ADR），安乃近用于婴儿术后疼痛治疗存在争议。目前尚缺乏大样本量的安全性研究。本前瞻性多中心观察性研究旨在评估安乃近在1岁以下接受手术的婴儿中的使用情况，特别关注可能出现的严重ADR（如血流动力学、过敏或呼吸反应以及粒细胞缺乏症）。纳入年龄达1岁（美国麻醉医师协会[ASA]分级I - III级）且接受单剂量安乃近进行术后疼痛治疗的婴儿。使用标准化病例报告表记录患者人口统计学资料、主要和次要诊断、所施行的外科手术、安乃近剂量、血流动力学数据、其他镇痛药和区域阻滞的使用情况、疼痛测量结果以及ADR发生率。五个儿科中心共观察了316例婴儿纳入分析（年龄4.4±3.7[0.06 - 12]个月）。安乃近平均剂量为17.8±3.1（9.2 - 29.8）mg·kg。在输注安乃近期间平均动脉压（MAP）保持稳定（输注前MAP为45±9.5[25 - 95]，输注后为45±9.2[25 - 99]mmHg）。1例患者出现红斑（ADR总计：0.3%，95%置信区间：0.27 - 0.32）。未报告与安乃近给药直接相关的呼吸不良事件，也未出现粒细胞缺乏症的临床体征。单剂量静脉注射安乃近用于预防或治疗术后疼痛在300多名1岁以下婴儿中是安全的。严重ADR（如血流动力学、过敏或呼吸反应）的统计概率低于1%。样本量和随访时间不足以检测出粒细胞缺乏症。
