Davies F C, Waters M
Arrowe Park Hospital, Upton, Wirral.
J Accid Emerg Med. 1998 Jul;15(4):244-8. doi: 10.1136/emj.15.4.244.
To compare the safety and efficacy of two doses of oral midazolam, and to assess the drug induced amnesia obtained, when used for conscious sedation of children undergoing minor procedures in the accident and emergency (A&E) setting.
A two stage trial was completed: an initial prospective, double blinded, randomised trial comparing 0.2 mg/kg midazolam suspension with 0.5 mg/kg, followed by further data collection on the higher dose. Children whom staff and parents felt required sedation for accurate and humane completion of minor procedures were selected. Anxiety was measured using physiological parameters, a behavioural anxiety score, a parental visual analogue scale, and a telephone questionnaire at 2-7 days after the procedure.
Fifty patients in total were recruited. Randomisation between two doses ceased after 20 patients since staff, despite being "blinded", perceived there to be a wide variation in response to midazolam and attributed that to the difference in doses. On breaking the code these suspicions were partly supported. Due to reluctance to continue with the lower dose all children subsequently received 0.5 mg/kg. At this higher dose oral midazolam had an onset of action of 15 minutes and was effective in 76% of children (as measured by anxiety score and/or subsequent amnesia). Amnesia was reported in 66% of children. There were no adverse side effects except paradoxical hyperagitation in three (6%); this did not require any specific treatment. General anaesthesia was avoided in at least eight children in whom the procedure would not have been attempted without midazolam. Altogether 90% of parents said they would like it to be used again should similar circumstances arise.
At 0.5 mg/kg oral midazolam appears safe and is effective in sedating most children for minor procedures. Its use should be considered by all A&E departments dealing with children.
比较两种剂量口服咪达唑仑的安全性和有效性,并评估在事故与急诊(A&E)环境中用于接受小手术的儿童清醒镇静时所产生的药物性遗忘效果。
完成了一项两阶段试验:最初进行一项前瞻性、双盲、随机试验,比较0.2mg/kg咪达唑仑混悬液与0.5mg/kg咪达唑仑混悬液,随后对高剂量组进行进一步数据收集。选择工作人员和家长认为需要镇静以准确且人道地完成小手术的儿童。在手术后2至7天,使用生理参数、行为焦虑评分、家长视觉模拟量表和电话调查问卷来测量焦虑程度。
共招募了50名患者。在20名患者之后,两剂量之间的随机分组停止,因为尽管工作人员“不知情”,但他们察觉到对咪达唑仑的反应存在很大差异,并将其归因于剂量差异。在破解密码后,这些怀疑得到了部分证实。由于不愿继续使用低剂量,所有儿童随后均接受0.5mg/kg的剂量。在此较高剂量下,口服咪达唑仑的起效时间为15分钟,76%的儿童有效(通过焦虑评分和/或随后的遗忘情况衡量)。66%的儿童出现了遗忘。除了3名儿童(6%)出现反常性多动外,没有其他不良副作用;这无需任何特殊治疗。至少8名儿童避免了全身麻醉,若没有咪达唑仑,这些儿童的手术本不会尝试进行。总共90%的家长表示,如果类似情况再次出现,他们希望再次使用该药。
口服咪达唑仑剂量为0.5mg/kg时似乎安全,且对大多数接受小手术的儿童有镇静效果。所有处理儿童患者的急诊部门都应考虑使用该药。