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用于白血病患儿腰椎穿刺疼痛的镇痛的固定氧化亚氮和氧气混合气体:一项随机、双盲对照试验。

A Fixed Nitrous Oxide and Oxygen Mixture for Analgesia in Children With Leukemia With Lumbar Puncture-induced Pain: A Randomized, Double-blind Controlled Trial.

机构信息

School of Nursing, Ningxia Medical University, Yinchuan, China; Ningxia Key Laboratory of Cerebrocranial Diseases, Department of Anatomy, Histology and Embryology, School of Basic Medical Sciences, Ningxia Medical University, Yinchuan, China.

School of Nursing, Ningxia Medical University, Yinchuan, China.

出版信息

J Pain Symptom Manage. 2019 Jun;57(6):1043-1050. doi: 10.1016/j.jpainsymman.2019.02.029. Epub 2019 Mar 8.

DOI:10.1016/j.jpainsymman.2019.02.029
PMID:30853549
Abstract

CONTEXT

Leukemia is the most common cancer in the childhood population. Lumbar puncture (LP) plays central role in the diagnosis and treatment process, but options for analgesia are limited.

OBJECTIVES

The present study aims to evaluate the efficacy of a fixed NO/O mixture to reduce pain in children with leukemia during LP as compared with placebo.

METHODS

A double-blind, placebo-controlled, and randomized clinical trial involving children who needed LP for diagnosis or treatment was conducted in the pediatrics department of the General Hospital of Ningxia Medical University. Eligible patients were randomly assigned to inhale either a fixed NO/O mixture or O. The primary endpoint was the maximal pain level felt by the patient during the procedure measured using a numerical rating scale (0-10).

RESULTS

One-hundred fourteen consecutive patients were enrolled in this study and randomized. Pain scores during the procedure showed a significant decrease in NO/O mixture-treated patients to 1.05 ± 1.40 versus 8.00 ± 2.13 in controls (P < 0.01). No serious adverse effects were attributed to NO/O mixture inhalation. Analysis of the satisfaction of patients receiving NO/O mixture indicated that medical staff were satisfied with this treatment.

CONCLUSIONS

This study demonstrated that self-administered fixed NO/O is efficient to reduce pain related to LP in children with leukemia.

摘要

背景

白血病是儿童中最常见的癌症。腰椎穿刺(LP)在诊断和治疗过程中起着核心作用,但镇痛选择有限。

目的

本研究旨在评估固定的一氧化氮/氧气混合物在与安慰剂相比,减轻白血病儿童 LP 期间疼痛的效果。

方法

在宁夏医科大学总医院儿科进行了一项双盲、安慰剂对照、随机临床试验,纳入需要 LP 进行诊断或治疗的儿童。符合条件的患者被随机分配吸入固定的一氧化氮/氧气混合物或氧气。主要终点是使用数字评分量表(0-10)测量患者在手术过程中感受到的最大疼痛程度。

结果

本研究共纳入 114 例连续患者并进行了随机分组。NO/O 混合物治疗组患者在手术过程中的疼痛评分显著降低至 1.05 ± 1.40,而对照组为 8.00 ± 2.13(P < 0.01)。没有将 NO/O 混合物吸入归因于严重的不良事件。对接受 NO/O 混合物治疗的患者满意度进行分析表明,医务人员对这种治疗方法感到满意。

结论

本研究表明,自我管理的固定的一氧化氮/氧气混合物可有效减轻白血病儿童 LP 相关疼痛。

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