Abstract

Children with cancer often require sedation before undergoing invasive procedures. Fentanyl, ketamine, and midazolam are effective drugs widely used for procedural sedation. This study aimed to investigate the efficacy and safety of midazolam-fentanyl (M-F) compared with midazolam-ketamine (M-K) for bedside procedural sedation among pediatric oncology patients. A randomized, double-blinded, crossover trial was conducted among children with cancer requiring procedural sedation for invasive procedures. Patients were randomly assigned either intravenous M-F or M-K and subsequently received the alternate regimens following the crossover design of the study. The efficacy and safety of the sedations including sedation time intervals, nausea score, vomiting episodes, pain score, adverse effects, and parent’s satisfaction were evaluated. In all, 58 patients with 116 procedural sedations were enrolled. M-K provided a shorter induction time (0:58 vs. 1:23 min) (p = 0.005), but longer sedation (9:02 vs. 5:50 min) (p = 0.019) and emergence time (4:26 vs. 0:56 min) (p = 0.011) compared with M-F. Sedation routes affected the sedation time intervals. Patients had higher rates of vomiting (0, range 0–8 vs. 0, range 0–2) (p = 0.033) but experienced less pain (0 vs. 2) (p = 0.008) in the M-K group. Overall satisfaction and other adverse effects were comparable among both sedation regimens. Combined sedative drugs are recommended to improve the effectiveness of bedside procedural sedation. M-K provided shorter induction, but longer sedation and emergence time compared with M-F. These findings correlated with sedative routes. Patients receiving M-K experienced a higher rate of vomiting, but less painfulness compared with M-F. Overall satisfaction and tolerable side effects were comparable among both sedative regimens.

摘要

患有癌症的儿童在进行侵入性手术之前通常需要镇静剂。芬太尼、氯胺酮和咪达唑仑是广泛用于程序镇静的有效药物。本研究旨在比较咪达唑仑-芬太尼 (MF) 与咪达唑仑-氯胺酮 (MK) 在儿科肿瘤患者床边程序镇静中的疗效和安全性。在需要对侵入性手术进行程序性镇静的癌症儿童中进行了一项随机、双盲、交叉试验。患者被随机分配静脉 MF 或 MK，随后在研究的交叉设计后接受替代方案。评估镇静剂的有效性和安全性，包括镇静时间间隔、恶心评分、呕吐发作、疼痛评分、不良反应和家长满意度。在所有，入组 58 名患者，使用 116 次程序性镇静剂。MK 提供了更短的诱导时间（0:58 对 1:23 分钟）（p  = 0.005），但与 MF 相比，镇静时间更长（9:02 对 5:50 分钟）（p  = 0.019）和出现时间（4:26 对 0:56 分钟）（p  = 0.011）。镇静路径影响镇静时间间隔。患者的呕吐率较高（0，范围 0-8 对 0，范围 0-2）（p  = 0.033）但疼痛较少（0 对 2）（p = 0.008) 在 MK 组中。两种镇静方案的总体满意度和其他不良反应具有可比性。推荐联合镇静药物以提高床边程序镇静的有效性。与 MF 相比，MK 提供更短的诱导时间，但更长的镇静和苏醒时间。这些发现与镇静剂途径相关。与 MF 相比，接受 MK 的患者呕吐率更高，但疼痛更少。两种镇静方案的总体满意度和可耐受的副作用具有可比性。