Liu Qiang, Wang Yu, Luo Xiang-Jiang, Wang Ning-Ju, Chen Ping, Jin Xin, Mu Guo-Xia, Chai Xiao-Min, Zhang Yue-Juan, Li Yu-Xiang, Yu Jian-Qiang
School of Nursing, Ningxia Medical University, 1160 Sheng Li Street, Yinchuan, 750004, China.
Yinchuan Guolong Hospital, 536 Chang Cheng Road, Xing Qing Area, Yinchuan, 750004, China.
Trials. 2017 Jan 11;18(1):13. doi: 10.1186/s13063-016-1739-9.
The management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient's and caregiver's quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain.
METHODS/DESIGN: This is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University. The target study subjects are at least 18 years old, and are hospitalized cancer patients who are receiving routine opioids to control cancer-related pain but still experience breakthrough pain. A total of 240 patients will be recruited and randomly allocated between three treatment groups (A, B, C) and a control group (group D) in a ratio of 3:1. All treatment groups (A, B, C) will receive standard pain treatment (oral immediate-release morphine) plus a pre-prepared nitrous oxide/oxygen mixture, and the control group (D) will receive the standard pain treatment plus oxygen. Patients, doctors, nurses, and data collectors are all blind to the experiment. Assessments will be taken before treatment (T0), at 5 min (T1) and 15 min (T2) during treatment, and at 5 min after treatment (T3). The primary endpoint measures will be the percentage of patients whose pain is relieved at T1, T2, and T3. Secondary outcome measures will include the safety of treatment, adverse events, and satisfaction from both health professionals and patients.
This study aims to provide an effective and practical intervention for a fast breakthrough pain relief and to improve cancer patients' quality of life significantly. The Evidence-Based Medicine Working Group claim that a randomized, double-blind, placebo-controlled experimental intervention is the most appropriate design to demonstrate its efficacy, so this study could give a new approach to controlling breakthrough pain episodes.
ChiCTR-INC-16008075 . Registered on 8 March 2016.
癌症患者爆发性疼痛的管理一直是医学专业人员面临的挑战。80%的晚期癌症患者会出现爆发性疼痛，这显著降低了患者及其护理人员的生活质量。本研究的目的是评估固定比例的吸入一氧化二氮/氧气混合气体对成年癌症爆发性疼痛患者的镇痛效果。
方法/设计：这是一项随机、安慰剂对照、双盲研究；将在宁夏医科大学总医院进行。目标研究对象为至少18岁的住院癌症患者，这些患者正在接受常规阿片类药物治疗以控制癌症相关疼痛，但仍经历爆发性疼痛。总共将招募240名患者，并按3:1的比例随机分配到三个治疗组（A、B、C）和一个对照组（D组）。所有治疗组（A、B、C）将接受标准疼痛治疗（口服即释吗啡）加预先制备的一氧化二氮/氧气混合气体，对照组（D）将接受标准疼痛治疗加氧气。患者、医生、护士和数据收集者均对实验不知情。将在治疗前（T0）、治疗期间的5分钟（T1）和15分钟（T2）以及治疗后5分钟（T3）进行评估。主要终点指标将是在T1、T2和T3时疼痛得到缓解的患者百分比。次要结局指标将包括治疗的安全性、不良事件以及医护人员和患者的满意度。
本研究旨在提供一种有效且实用的干预措施，以快速缓解爆发性疼痛并显著提高癌症患者的生活质量。循证医学工作组声称，随机、双盲、安慰剂对照的实验性干预是证明其疗效的最合适设计，因此本研究可为控制爆发性疼痛发作提供一种新方法。
ChiCTR-INC-16008075。于2016年3月8日注册。
