From the Department of Surgical and Perioperative Sciences, Anesthesiology and Intensive Care Medicine, Umeå University, Umeå, Sweden.
Anesth Analg. 2022 Aug 1;135(2):307-315. doi: 10.1213/ANE.0000000000005915. Epub 2022 Feb 24.
Postoperative negative behavioral changes (NBCs) are common among children, but risk for this is thought to be reduced with premedication. Midazolam has for many years been a standard premedication for children. More recently, the alpha-2 adrenergic agonist clonidine has also become popular as a preanesthetic sedative. We hypothesized that clonidine was superior to midazolam for limiting new NBCs in children as assessed using the Post Hospital Behavior Questionnaire (PHBQ).
This was a prospective, randomized, controlled, blinded study, including 115 participants aged 24 to 95 months and their parents. The participants underwent ear, nose, or throat outpatient surgery and were randomly allocated to premedication with oral midazolam 0.5 mg/kg or oral clonidine 4 µg/kg. Participants were anesthetized by protocol. At home, later, parents were asked to complete the PHBQ assessment instrument for postoperative NBCs for the participants 1 week, 1 month, and 6 months after the surgery. A secondary outcome, preinduction anxiety, was assessed using modified Yale Preoperative Anxiety Scale (mYPAS).
The primary outcome, more than 3 NBCs in an individual case at 1 week, showed no difference in proportions between treatment in the clonidine group compared to the midazolam group, (12/59 or 20% vs 7/56 or 13%, respectively, odds ratio 1.39, 95% confidence interval [CI], 0.75-2.58; P = .32). A secondary result showed a higher preinduction anxiety level in the clonidine compared to the midazolam group (mYPAS >30, 43/59 or 71% vs 12/56 or 21%, respectively; P < .001).
These results did not show a clinical or statistically significant difference, with respect to the primary outcome of behavior changes at 1 week, between the cohorts that received midazolam versus clonidine as a premedication.
术后负面行为改变（NBCs）在儿童中很常见，但人们认为使用术前药物可以降低这种风险。咪达唑仑多年来一直是儿童的标准术前用药。最近，α-2 肾上腺素能激动剂可乐定也成为一种流行的术前镇静剂。我们假设，使用术后行为问卷（PHBQ）评估时，氯胺酮在限制儿童新 NBCs 方面优于咪达唑仑。
这是一项前瞻性、随机、对照、盲法研究，纳入了 115 名年龄在 24 至 95 个月的患儿及其父母。这些患儿接受耳鼻喉科门诊手术，随机分为口服咪达唑仑 0.5mg/kg 或口服可乐定 4μg/kg 进行术前用药。根据方案对患儿进行麻醉。术后 1 周、1 个月和 6 个月，在家中，父母被要求使用 PHBQ 评估工具评估患儿的术后 NBCs。次要结果为术前焦虑，使用改良耶鲁术前焦虑量表（mYPAS）评估。
主要结局为个体病例在 1 周时出现超过 3 个 NBCs，氯胺酮组与咪达唑仑组之间的比例无差异（分别为 12/59 或 20%与 7/56 或 13%，比值比 1.39，95%置信区间[CI]，0.75-2.58；P =.32）。次要结果显示氯胺酮组的术前焦虑水平高于咪达唑仑组（mYPAS >30，43/59 或 71%与 12/56 或 21%，P <.001）。
在接受咪达唑仑与氯胺酮作为术前用药的两组患儿中，就 1 周时行为改变的主要结局而言，两组之间未显示出临床或统计学上的显著差异。
