未经批准:通过添加糖浆掩盖其苦味来研究咪达唑仑静脉内(IV)溶液的耐受性。
未经评估:在我们机构手术前的等候区,眼科和耳鼻喉科医院,从2021年5月至11月,计划进行耳前瘘摘除或耳膜导管插入术的儿科患者被随机分配接受等量的IV咪达唑仑和水的混合物(C组)或IV咪达唑仑和糖浆的混合物(S组).我们用给每位患者的5点面部快感量表测量了两组之间在药物耐受性方面的差异,父母,和护士参与了这项研究。次要结果包括镇静和焦虑水平,在与父母分离和通过面罩进行全身麻醉诱导时进行评估。
未经批准:总共,180名患者入选。根据儿童的评估,S组的面部快感量表较高(p=0.046),父母(p=0.020),和护士(p=0.026)。与C组相比,S组中更多的患者愿意再次服用相同的溶液(p=0.024)。两组之间在两个时间点的镇静和焦虑水平相似(均p>0.05)。术前没有发现不良事件。
UNASSIGNED:通过添加糖浆,在儿科人群中口服静脉注射咪达唑仑的耐受性增加。两种咪达唑仑混合物的镇静和抗焦虑作用相当。
未经批准:中国临床研究信息服务,ChiCTR2000040229。
UNASSIGNED: To investigate the tolerability of midazolam intravenous (IV) solution by masking its bitter taste through the addition of syrup.
UNASSIGNED: In the waiting area before surgery at our institution, Eye and ENT Hospital, from May to November of 2021, pediatric patients scheduled for anterior ear fistula removal or eardrum catheterization were randomly assigned to receive a mixture of IV midazolam and water (Group C) or IV midazolam and syrup (Group S) in equal volumes. We measured the difference between the groups in terms of drug tolerability with a 5-point facial hedonic scale given to every patient, parent, and nurse involved in the study. Secondary outcomes included sedation and anxiety levels, which were assessed at separation from the parents and general anesthesia induction via a mask.
UNASSIGNED: In total, 180 patients were enrolled. The facial hedonic scales were higher in Group S as evaluated by the children (p=0.046), parents (p=0.020), and nurses (p=0.026). More patients were willing to take the same solution again in Group S than in Group C (p=0.024). The levels of sedation and anxiety at two timepoints were similar between the groups (all p>0.05). No adverse events were noted preoperatively.
UNASSIGNED: The tolerability of IV midazolam administered orally was increased in a pediatric population by adding syrup. The sedative and anxiolytic effects were comparable for both midazolam mixtures.
UNASSIGNED: China Clinical Research Information Service, ChiCTR2000040229.