Lökken P, Bakstad O J, Fonnelöp E, Skogedal N, Hellsten K, Bjerkelund C E, Storhaug K, Oye I
Section of Dental Pharmacology and Pharmacotherapeutics, University of Oslo, Norway.
Scand J Dent Res. 1994 Oct;102(5):274-80. doi: 10.1111/j.1600-0722.1994.tb01468.x.
The trial included 24 children (aged 2-7 yr) referred for dental treatment under general anesthesia, since conventional behavioral management methods had failed to achieve treatment acceptance. As an alternative, they received, on two separate occasions with "identical" dental treatment, conscious sedation by rectal administration of either midazolam (0.3 mg/kg body weight (bwt)) or midazolam (0.3 mg/kg bwt) plus ketamine (1.0 mg/kg bwt). This allowed a double-blind, crossover design. The aims were to assess conscious sedation, combined with local anesthesia, as an alternative to general anesthesia, and further to evaluate the effects obtained by addition of a low dose of ketamine to rectally administered midazolam. The feasibility of dental treatment was rated as excellent or good for 16 of the 24 children when premedicated with midazolam, and for 18 of the 24 children when ketamine was added to midazolam. At least some treatment could be given to all children. Verbal contact was maintained with all children throughout both treatment sessions. The children were significantly less anxious when they arrived for the second session. Amnesia and drowsiness were significantly increased when ketamine was added to midazolam. The combination also tended to be more efficient in relief of anxiety and prevention of pain, but there were large variations in the children's responses to the drugs. Midazolam significantly reduced the blood oxygen level, but not with ketamine added. For most children, both regimens proved to be appropriate as alternatives to general anesthesia.(ABSTRACT TRUNCATED AT 250 WORDS)
该试验纳入了24名2至7岁因常规行为管理方法未能使患儿接受牙科治疗而需在全身麻醉下接受治疗的儿童。作为替代方案,他们在两个不同场合接受“相同”的牙科治疗,通过直肠给予咪达唑仑(0.3毫克/千克体重)或咪达唑仑(0.3毫克/千克体重)加氯胺酮(1.0毫克/千克体重)进行清醒镇静。这采用了双盲交叉设计。目的是评估清醒镇静联合局部麻醉作为全身麻醉的替代方案,并进一步评估在直肠给予的咪达唑仑中添加低剂量氯胺酮所产生的效果。在使用咪达唑仑进行术前用药时,24名儿童中有16名的牙科治疗可行性被评为优秀或良好;在咪达唑仑中添加氯胺酮时,24名儿童中有18名的治疗可行性被评为优秀或良好。所有儿童至少都能接受一些治疗。在两个治疗过程中均与所有儿童保持了言语交流。儿童在第二次治疗时焦虑程度显著降低。在咪达唑仑中添加氯胺酮后,遗忘和嗜睡情况显著增加。这种联合用药在缓解焦虑和预防疼痛方面也往往更有效,但儿童对药物的反应差异很大。咪达唑仑显著降低了血氧水平,但添加氯胺酮后则没有。对大多数儿童来说,两种方案都被证明是全身麻醉的合适替代方案。(摘要截选至250字)