鼻内可乐定预防儿童围手术期焦虑的研究：一项前瞻性随机试验。
The interest of intranasal clonidine in the prevention of perioperative children's anxiety: a prospective randomized trial.
作者信息
Keskes Mariem, Amouri Nouha, Ketata Salma, Derbel Rahma, Charfi Maha, Zouche Imen, Sallemi Moncef, Elloumi Moez, Chikhrouhou Hichem
机构信息
Department of Anesthesiology and Intensive Care Unit, Habib Bourguiba University Hospital, Sfax, Tunisia.
Department of Hematology, Hedi Chaker Hospital, Sfax, Tunisia.
出版信息
Pan Afr Med J. 2023 Sep 25;46:37. doi: 10.11604/pamj.2023.46.37.40310. eCollection 2023.
INTRODUCTION
perioperative anxiety in children may lead to psychological and physiological side effects. Clonidine is in increasing use in the pediatric population as an anxiolytic, sedative, and analgesic because of its central alpha2-adrenergic agonist effect. Our study aimed to evaluate the effect of clonidine in the prevention of perioperative children´s anxiety.
METHODS
we conducted a prospective controlled randomized double-blinded clinical trial including children aged between 2 and 15 years undergoing tonsillectomy surgery. The patients were randomly allocated to receive either an intranasal dose of clonidine (4 μg/kg) (clonidine group) or an equal volume dose of saline solution (control group) 30 minutes before entering the operating room. The level of anxiety assessed using the m-YPAS score was recorded before premedication, at the time of parent-child separation, and at the time of installation in the operating room. Acceptance of premedication, degree of sedation on entering the operating room as well as agitation on awakening, and sedation on arrival post-anesthesia care unit were noted. Adverse effects were recorded during the surgical procedure and in the postoperative recovery room.
RESULTS
the number of patients analyzed was 78 with 39 patients in each group. There were no signification differences in demographic data and premedication acceptance between the two groups. Levels of anxiety before any premedication were similar in the two groups. However, the anxiety level 30 minutes after premedication and in the operating room was significantly lower in the clonidine group (p<0.001). Children who received clonidine showed better sedation on entering the operating room (p=0.002) as well as postoperatively on entering the post-anesthesia unit care (p=0.006). The hemodynamic and respiratory parameters recorded were statistically comparable.
CONCLUSION
intranasal clonidine is an interesting premedication to prevent perioperative children´s anxiety with few side effects.
引言
儿童围手术期焦虑可能会导致心理和生理方面的副作用。可乐定因其中枢α2肾上腺素能激动剂作用，在儿科人群中作为抗焦虑药、镇静剂和镇痛药的使用越来越多。我们的研究旨在评估可乐定在预防儿童围手术期焦虑方面的效果。
方法
我们进行了一项前瞻性对照随机双盲临床试验，纳入年龄在2至15岁接受扁桃体切除术的儿童。患者在进入手术室前30分钟被随机分配接受鼻内剂量的可乐定（4μg/kg）（可乐定组）或等体积剂量的盐溶液（对照组）。使用m-YPAS评分评估的焦虑水平在术前用药前（即术前）、亲子分离时以及进入手术室时进行记录。记录术前用药的接受情况、进入手术室时的镇静程度以及苏醒时的躁动情况，还有到达麻醉后护理单元时的镇静情况。在手术过程中和术后恢复室记录不良反应。
结果
分析的患者数量为78例，每组39例。两组在人口统计学数据和术前用药接受情况方面没有显著差异。两组在任何术前用药前的焦虑水平相似。然而，可乐定组在术前用药30分钟后以及在手术室中的焦虑水平显著较低（p<0.001）。接受可乐定的儿童在进入手术室时（p = 0.002）以及术后进入麻醉后护理单元时（p = 0.006）表现出更好的镇静效果。记录的血流动力学和呼吸参数在统计学上具有可比性。
结论
鼻内给予可乐定是一种用于预防儿童围手术期焦虑且副作用较少的有趣的术前用药。
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