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右美托咪定-氯胺酮联合用药与右美托咪定对不合作小儿牙科患者行为影响的随机对照临床试验。

The effect of dexmedetomidine-ketamine combination versus dexmedetomidine on behavior of uncooperative pediatric dental patients: a randomized controlled clinical trial.

机构信息

Alexandria University, Faculty of Dentistry, Pediatric Dentistry and Dental Public Health Department, Egypt.

NYU College of Dentistry, Department of Pediatric Dentistry, USA.

出版信息

J Appl Oral Sci. 2024 Sep 20;32:e20240057. doi: 10.1590/1678-7757-2024-0057. eCollection 2024.

Abstract

OBJECTIVE

Uncooperative behavior in pediatric dentistry is one of the most common manifestations of dental anxiety. Managing anxious patients can be attained by moderate sedation. This study aimed to compare the effect of sedation by dexmedetomidine-ketamine combination (DEX-KET) versus dexmedetomidine (DEX) on behavior of uncooperative pediatric dental patients.

METHODOLOGY

In total, 56 uncooperative healthy children (3-5 years old) requiring dental treatment were divided randomly into two groups: Group I (study group), which received buccal dexmedetomidine (2 μg/kg) and ketamine (2 mg/kg), and Group II (control group), which received only buccal dexmedetomidine (4 μg/kg). Drugs effects were assessed in terms of hemodynamic parameters, patient's drug acceptance, child behavior, postoperative effect of sedation, amnesic effect, incidence of adverse events, as well as procedural induced stress measured by salivary secretory immunoglobulin A (s-IgA).

RESULTS

Hemodynamic results did not reveal a statistically significant difference between the two study groups (P>0.05). There was a significant difference in patient's acceptance to sedative drug between both groups, favoring DEX (p=0.005). Children who received DEX-KET showed significantly better behavior than those who received DEX for local anesthesia (p=0.017) and during operative procedure (p=0.037). Adverse events, post-operative and amnesic effects of drugs were comparable in both groups (p>0.05). Moreover, the mean difference in the salivary s-IgA levels between initial and final value was not statistically significant between both groups (p=0.556).

CONCLUSION

Both DEX-KET combination and DEX alone are effective in providing hemodynamic stability. DEX-KET combination significantly improved the behavior of sedated children compared to DEX alone but the drug acceptance was decreased in the DEX-KET group. Both regimens did not have a negative effect on postoperative behavior of children and had comparable amnesic effect with no significant adverse events. Salivary s-IgA is not considered a potential stress biomarker in sedated children.

摘要

目的

小儿牙科中的不合作行为是牙科焦虑症最常见的表现之一。通过适度镇静可以管理焦虑患者。本研究旨在比较右美托咪定-氯胺酮联合(DEX-KET)与右美托咪定(DEX)镇静对不合作的小儿牙科患者行为的影响。

方法

共有 56 名需要牙科治疗的不合作健康儿童(3-5 岁)随机分为两组:I 组(研究组),给予颊部右美托咪定(2μg/kg)和氯胺酮(2mg/kg);II 组(对照组),给予颊部右美托咪定(4μg/kg)。通过评估血流动力学参数、患者对药物的接受程度、儿童行为、镇静后效果、遗忘效果、不良事件发生率以及唾液分泌免疫球蛋白 A(s-IgA)测量的操作诱导应激来评估药物作用。

结果

两组间血流动力学结果无统计学差异(P>0.05)。两组间患者对镇静药物的接受程度存在显著差异,DEX 组更优(p=0.005)。接受 DEX-KET 的儿童在局部麻醉和手术过程中的行为明显优于接受 DEX 的儿童(p=0.017 和 p=0.037)。两组的药物不良反应、术后和遗忘效果相当(p>0.05)。此外,两组间唾液 s-IgA 水平在初始值和终值之间的平均差值无统计学意义(p=0.556)。

结论

DEX-KET 联合和单独使用 DEX 均可提供血流动力学稳定性。DEX-KET 联合治疗可显著改善镇静儿童的行为,优于单独使用 DEX,但 DEX-KET 组的药物接受程度降低。两种方案对儿童术后行为均无不良影响,遗忘效果相当,无明显不良事件。唾液 s-IgA 不作为镇静儿童的潜在应激生物标志物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d85a/11464076/41a33fdaa65e/1678-7757-jaos-32-e20240057-gf01.jpg

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