Aghadavoudi Omid, Shetabi Hamidreza, Dezfouli Zahra Saedi
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Turk J Anaesthesiol Reanim. 2020 Apr;48(2):120-126. doi: 10.5152/TJAR.2019.42402. Epub 2019 Oct 8.
Bone marrow aspiration and lumbar puncture play essential roles in the diagnosis and treatment of haematological disorders. These repeated invasive procedures lead to considerable pain and stress in children, which is emotionally stressful for their parents. This study aimed to compare the effectiveness and outcomes of two combinations of midazolam-ketamine (MK) and propofol-sufentanil (PS) in painful procedures of children with haematologic malignancy.
In this prospective, randomised, double-blind clinical trial, we enrolled 80 eligible patients with haematologic malignancy aged 2-14 years. We randomly allocated them to the MK and PS groups. We recorded and compared the level of sedation, pain severity, hemodynamic indices, the onset of effect, duration of recovery and complications during and after procedure in the two groups. We analysed the data using the SPSS software. We used Mann-Whitney U, independent t-test, chi-square and Fisher's exact tests to compare continuous and categorical variables.
From initially enrolled patients, 68 patients completed the study (38 in PS and 30 in MK group). The levels of sedation and the mean score of pain intensity were significantly lower in the MK group than those in the PS group (p<0.05). Movements and the needs to repeat the dose were significantly lower in the MK group than those in the PS group (p<0.05).
During bone marrow aspiration and lumbar puncture procedures in children with haematologic malignancy, the findings of this trial suggest that MK combination therapy provides better sedation and analgesia than PS.
骨髓穿刺和腰椎穿刺在血液系统疾病的诊断和治疗中发挥着重要作用。这些反复的侵入性操作会给儿童带来相当大的疼痛和压力,也会让他们的父母在情感上感到紧张。本研究旨在比较咪达唑仑-氯胺酮(MK)和丙泊酚-舒芬太尼(PS)两种组合在血液系统恶性肿瘤患儿痛苦操作中的有效性和结果。
在这项前瞻性、随机、双盲临床试验中,我们纳入了80名年龄在2至14岁的符合条件的血液系统恶性肿瘤患者。我们将他们随机分配到MK组和PS组。我们记录并比较了两组在操作过程中和操作后镇静水平、疼痛严重程度、血流动力学指标、起效时间、恢复时间和并发症情况。我们使用SPSS软件分析数据。我们使用曼-惠特尼U检验、独立t检验、卡方检验和费舍尔精确检验来比较连续变量和分类变量。
从最初纳入的患者中,68名患者完成了研究(PS组38名,MK组30名)。MK组的镇静水平和疼痛强度平均评分显著低于PS组(p<0.05)。MK组的活动和重复给药需求显著低于PS组(p<0.05)。
在血液系统恶性肿瘤患儿的骨髓穿刺和腰椎穿刺操作中,本试验结果表明MK联合治疗比PS提供更好的镇静和镇痛效果。