Department of Anaesthesiology, University Hospital La Paz, Madrid, Spain.
Pediatrics. 2011 Jun;127(6):e1464-70. doi: 10.1542/peds.2010-1142. Epub 2011 May 23.
This randomized, single-dose, double-blind, Phase III study was designed to compare the level of procedural pain after use of premixed equimolar mixture of 50% oxygen and nitrous oxide (EMONO) or placebo (premixed 50% nitrogen and oxygen).
Patients aged 1 to 18 years were randomly assigned to receive EMONO (n = 52) or placebo (n = 48) delivered by inhalation through a facial mask 3 minutes before cutaneous, muscle, or bone/joint procedures. Pain was evaluated (on a scale from 0-10) using a self-reported Faces Pain Scale-Revised (FPS-R) or a Spanish observational pain scale (LLANTO). Rescue analgesia (with propofol or sevoflurane) was administered if pain scores were greater than or equal to 8. Collaboration, acceptance, ease of use and safety were evaluated by the attending nurse.
There were significant differences between the 2 groups (EMONO versus placebo) for both scales (mean values): LLANTO: 3.5 vs 6.7, respectively (P = .01) and FPS-R: 3.2 vs 6.6, respectively (P = .0003). Patients not receiving EMONO (P = .0208)-in particular those aged younger than 3 years (P < .0001)-required more rescue analgesia. There were also significant differences between the 2 groups (EMONO versus placebo) for adequate collaboration (80% vs 35%; P < .0001) and acceptance (73% vs 25%; P < .0001). Ease of use was not significantly different between groups (98.1% vs 95.8%; P > .05). Only 2 patients (in the EMONO group) presented with mild adverse events.
EMONO inhalation was well tolerated and had an estimated analgesic potency of 50%, and it is therefore suitable for minor pediatric procedures.
本随机、单剂量、双盲、III 期研究旨在比较使用预混等摩尔混合 50%氧气和一氧化二氮（EMONO）或安慰剂（预混 50%氮气和氧气）后程序疼痛的程度。
1 至 18 岁的患者被随机分配接受 EMONO（n=52）或安慰剂（n=48），通过面罩吸入 3 分钟后进行皮肤、肌肉或骨骼/关节操作。使用自我报告的面部疼痛评分修订版（FPS-R）或西班牙语观察疼痛量表（LLANTO）评估疼痛（评分范围为 0-10）。如果疼痛评分大于或等于 8，则给予补救镇痛（异丙酚或七氟醚）。由值班护士评估协作、接受、易用性和安全性。
在两个组（EMONO 与安慰剂）的两个量表（平均值）之间均存在显著差异：LLANTO：分别为 3.5 与 6.7（P=0.01）和 FPS-R：分别为 3.2 与 6.6（P=0.0003）。未接受 EMONO 的患者（P=0.0208）-特别是年龄小于 3 岁的患者（P<0.0001）-需要更多的补救镇痛。在协作（80%与 35%；P<0.0001）和接受程度（73%与 25%；P<0.0001）方面，两组之间也存在显著差异。使用方便性在两组之间无显著差异（98.1%与 95.8%；P>0.05）。只有 2 名患者（EMONO 组）出现轻度不良反应。
EMONO 吸入耐受性良好，估计镇痛效力为 50%，因此适用于小儿小手术。
