Marx C M, Stein J, Tyler M K, Nieder M L, Shurin S B, Blumer J L
Department of Pediatrics, Case Western Reserve University, School of Medicine, Cleveland, OH, USA.
J Clin Oncol. 1997 Jan;15(1):94-102. doi: 10.1200/JCO.1997.15.1.94.
To compare the efficacy, characteristics of onset/recovery, and safety of ketamine/atropine/midazolam with meperidine/midazolam used as premedication for painful procedures in children with cancer.
A randomized, double-blind crossover trial for two successive painful procedures (bone marrow aspiration or biopsy, lumbar puncture, or combined procedures) was performed at a referral-based pediatric hematology-oncology clinic and associated inpatient service of a university teaching hospital. Twenty-two children, aged 24 to 178 months, were enrolled and 18 (81.8%) completed the double-blind, crossover trial. Each child received intravenous premedication with either meperidine 2 mg/kg and midazolam 0.1 mg/kg (MM) or atropine 0.01 mg/kg, midazolam 0.05 mg/kg, and ketamine 1.5 mg/kg (KM) on one occasion followed by the alternative regimen on a second occasion. The initial premedication regimen was chosen by random assignment.
Efficacy was assessed by a trained observer using the Observational Scale of Behavioral Distress-Revised (OSBD-R). Operator, nurse, parent, and patient opinions of efficacy were recorded on a visual analog scale (VAS). Side effects were monitored by pulse oximetry, nasal end-tidal capnography, and serial blood pressure measurements. Use of KM resulted in significantly less procedural distress than MM (1.37 +/- 2.20 v 7.04 +/- 8.06 OSBD-R units; P < .05). Both operators and nurses rated KM more effective than MM. KM use was associated with earlier readiness for the procedure (19.2 v 24.0 minutes) and more rapid recovery (39.3 v 74.6 minutes for removal of monitoring devices and 58.5 v 87.1 minutes for discharge). Procedures undertaken after ketamine sedation were associated with fewer side effects than observed with MM sedation (hypoxia, 17.7% v 82.4%; hypotension, 16.6% v 55.6%; reduced respiratory rate, 0% v 38.9%). The incidence of emergence reactions or behavioral abnormalities within 24 hours postprocedure was similar in both treatment groups. At 7 days postprocedure, no child had persistent behavioral abnormalities and all children had amnesia for the procedure. Parents and children expressed a preference for KM over MM in 12 of 18 cases (P < .05).
A premedication regimen of KM produced superior sedation with a faster onset and recovery and fewer side effects than a MM combination.
比较氯胺酮/阿托品/咪达唑仑与哌替啶/咪达唑仑作为癌症患儿疼痛性操作术前用药的疗效、起效/恢复特点及安全性。
在一家大学教学医院的儿科血液肿瘤转诊诊所及相关住院部,针对两项连续的疼痛性操作(骨髓穿刺或活检、腰椎穿刺或联合操作)进行了一项随机、双盲交叉试验。纳入了22名年龄在24至178个月的儿童,18名(81.8%)完成了双盲交叉试验。每个儿童在一次操作时接受静脉注射哌替啶2mg/kg和咪达唑仑0.1mg/kg(MM)或阿托品0.01mg/kg、咪达唑仑0.05mg/kg和氯胺酮1.5mg/kg(KM)作为术前用药,另一次操作时采用替代方案。初始术前用药方案通过随机分配选择。
由一名经过培训的观察者使用修订的行为痛苦观察量表(OSBD-R)评估疗效。在视觉模拟量表(VAS)上记录操作者、护士、家长和患者对疗效的意见。通过脉搏血氧饱和度测定、鼻腔呼气末二氧化碳监测和连续血压测量监测副作用。使用KM导致的操作痛苦明显少于MM(1.37±2.20对7.04±8.06 OSBD-R单位;P<.05)。操作者和护士都认为KM比MM更有效。使用KM与更早准备好进行操作(19.2对24.0分钟)和更快恢复(移除监测设备分别为39.3对74.6分钟,出院分别为58.5对87.1分钟)相关。氯胺酮镇静后进行的操作比MM镇静观察到的副作用更少(低氧血症,17.7%对82.4%;低血压,16.6%对55.6%;呼吸频率降低,0%对38.9%)。两个治疗组术后24小时内出现反应或行为异常的发生率相似。术后7天,没有儿童有持续的行为异常,所有儿童对操作都有遗忘。18例中有12例家长和儿童表示更喜欢KM而不是MM(P<.05)。
与MM联合用药相比,KM术前用药方案产生了更好的镇静效果,起效更快、恢复更快且副作用更少。