Impellizzeri Pietro, Vinci Enrica, Gugliandolo Maria Cristina, Cuzzocrea Francesca, Larcan Rosalba, Russo Tiziana, Gravina Maria Rosaria, Arena Salvatore, D'Angelo Gabriella, Gitto Eloisa, Montalto Angela Simona, Alibrandi Angela, Marseglia Lucia, Romeo Carmelo
Unit of Pediatric Surgery, University of Messina, Messina, Italy.
Department of Psychology, University of Messina, Messina, Italy.
Eur J Pediatr. 2017 Jul;176(7):947-953. doi: 10.1007/s00431-017-2933-9. Epub 2017 May 24.
Preoperative anxiety is a major problem in paediatric surgical patients. Melatonin has been used as a premedicant agent and data regarding effectiveness are controversial. The primary outcome of this randomized clinical trial was to evaluate the effectiveness of oral melatonin premedication, in comparison to midazolam, in reducing preoperative anxiety in children undergoing elective surgery. As secondary outcome, compliance to intravenous induction anaesthesia was assessed. There were 80 children undergoing surgery randomly assigned, 40 per group, to receive oral midazolam (0.5 mg/kg, max 20 mg) or oral melatonin (0.5 mg/kg, max 20 mg). Trait anxiety of children and their mothers (State-Trait Anxiety Inventory) at admission, preoperative anxiety and during anaesthesia induction (Modified Yale Pre-operative Anxiety Scale), and children's compliance with anaesthesia induction (Induction Compliance Checklist) were all assessed. Children premedicated with melatonin and midazolam did not show significant differences in preoperative anxiety levels, either in the preoperative room or during anaesthesia induction. Moreover, compliance during anaesthesia induction was similar in both groups.
This study adds new encouraging data, further supporting the potential use of melatonin premedication in reducing anxiety and improving compliance to induction of anaesthesia in children undergoing surgery. Nevertheless, further larger controlled clinical trials are needed to confirm the real effectiveness of melatonin as a premedicant agent in paediatric population. What is Known: • Although midazolam represents the preferred treatment as a premedication for children before induction of anaesthesia, it has several side effects. • Melatonin has been successfully used as a premedicant agent in adults, while data regarding effectiveness in children are controversial. What is New: • In this study, melatonin was as effective as midazolam in reducing children's anxiety in both preoperative room and at induction of anaesthesia.
术前焦虑是小儿外科手术患者的一个主要问题。褪黑素已被用作术前用药，但其有效性的数据存在争议。这项随机临床试验的主要结果是评估口服褪黑素术前用药与咪达唑仑相比，在减轻择期手术儿童术前焦虑方面的有效性。作为次要结果，评估了对静脉诱导麻醉的依从性。有80名接受手术的儿童被随机分组，每组40名，分别接受口服咪达唑仑（0.5毫克/千克，最大20毫克）或口服褪黑素（0.5毫克/千克，最大20毫克）。评估了儿童及其母亲入院时的特质焦虑（状态-特质焦虑量表）、术前焦虑以及麻醉诱导期间的焦虑（改良耶鲁术前焦虑量表），以及儿童对麻醉诱导的依从性（诱导依从性检查表）。用褪黑素和咪达唑仑进行术前用药的儿童在术前病房或麻醉诱导期间的术前焦虑水平均无显著差异。此外，两组在麻醉诱导期间的依从性相似。
本研究增加了新的令人鼓舞的数据，进一步支持了褪黑素术前用药在减轻接受手术儿童的焦虑和提高麻醉诱导依从性方面的潜在用途。然而，需要进一步进行更大规模的对照临床试验来证实褪黑素作为小儿术前用药的实际有效性。已知信息：• 尽管咪达唑仑是儿童麻醉诱导前首选的术前用药，但它有几种副作用。• 褪黑素已在成人中成功用作术前用药，而关于其在儿童中有效性的数据存在争议。新发现：• 在本研究中，褪黑素在减轻儿童术前病房和麻醉诱导时的焦虑方面与咪达唑仑一样有效。
