Health Sciences Graduate Program, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.
Dentistry Graduate Program, Faculdade de Odontologia, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.
PLoS One. 2019 Mar 11;14(3):e0213074. doi: 10.1371/journal.pone.0213074. eCollection 2019.
The optimal sedative regime that provides the greatest comfort and the lowest risk for procedural sedation in young children remains to be determined. The aim of this randomized, blinded, controlled, parallel-design trial was to evaluate the efficacy of intranasal ketamine and midazolam as the main component of the behavioral guidance approach for preschoolers during dental treatment.
Children under seven years of age, with caries and non-cooperative behavior, were randomized into three groups: (KMIN) intranasal ketamine and midazolam; (KMO) oral ketamine and midazolam; or (MO) oral midazolam. The dental sedation appointments were videotaped, and the videos were analyzed using the Ohio State University Behavioral Rating Scale (OSUBRS) to determine the success of the sedation in each group. Intra- and postoperative adverse events were recorded. Data analysis involved descriptive statistics and non-parametric tests (P < 0.05, IBM SPSS).
Participants were 84 children (28 per group; 43 boys), with a mean age of 3.1 years (SD 1.2). Children's baseline and the dental sedation session characteristics were balanced among groups. The success of the treatment as assessed by the dichotomous variable 'quiet behavior for at least 60% of the session length' was: KMIN 50.0% (n = 14; OR 2.10, 95% CI 0.71 to 6.30), KMO 46.4% (n = 13; OR 1.80, 95% CI 0.62 to 5.40), MO 32.1% (n = 9) (P = 0.360). Adverse events were minor, occurred in 37 of 84 children (44.0%), and did not differ among groups (P = 0.462).
All three regimens provided moderate dental sedation with minor adverse events, with marked variability in the behavior of children during dental treatment. The potential benefit of the ketamine-midazolam combination should be further investigated in studies with larger samples.
ClinicalTrials.gov, identifier: NCT02447289. Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."
为了确定在幼儿中进行程序镇静时，哪种镇静方案能提供最大舒适度和最低风险，仍需进一步研究。本随机、双盲、对照、平行设计的临床试验旨在评估鼻腔内给予氯胺酮和咪达唑仑作为学龄前儿童行为指导方法主要成分，在口腔治疗中的效果。
将患有龋齿且行为不配合的 7 岁以下儿童随机分为三组：（KMIN）鼻腔内给予氯胺酮和咪达唑仑；（KMO）口服氯胺酮和咪达唑仑；或（MO）口服咪达唑仑。每次口腔镇静治疗均进行录像，采用俄亥俄州立大学行为评定量表（OSUBRS）对录像进行分析，以确定每组的镇静效果。记录术中及术后不良事件。数据分析采用描述性统计和非参数检验（P＜0.05，IBM SPSS）。
共有 84 名儿童（每组 28 名，男孩 43 名）参与研究，平均年龄为 3.1 岁（标准差 1.2）。组间儿童的基线和口腔镇静治疗期间的特征基本均衡。通过二项变量“安静行为至少占疗程 60%”评估的治疗成功率为：KMIN 组 50.0%（n=14；OR 2.10，95%CI 0.71-6.30），KMO 组 46.4%（n=13；OR 1.80，95%CI 0.62-5.40），MO 组 32.1%（n=9）（P=0.360）。不良事件均为轻微事件，84 名儿童中有 37 名（44.0%）发生，且组间无差异（P=0.462）。
三种方案均能提供中度的口腔镇静效果，且不良事件轻微，但儿童在口腔治疗过程中的行为存在显著差异。应进一步研究更大样本量的研究，以确定氯胺酮-咪达唑仑联合应用的潜在益处。
ClinicalTrials.gov，标识符：NCT02447289。于 2015 年 5 月 11 日注册，命名为“鼻腔内给予咪达唑仑和氯胺酮用于儿童牙科治疗镇静（NASO）”。
