School of Nursing, Ningxia Medical University, 1160 Sheng Li Street, Yinchuan, 750004, China.
Intensive Care Unit, The Second People's Hospital of Yinchuan, 684 Bei Jing Street, Yinchuan, 750011, China.
Trials. 2021 Jan 6;22(1):29. doi: 10.1186/s13063-020-04960-5.
The pain management of postherpetic neuralgia (PHN) remains a major challenge, with no immediate relief. Nitrous oxide/oxygen mixture has the advantages of quick analgesic effect and well-tolerated. The purpose of this study is to investigate the analgesic effect and safety of nitrous oxide/oxygen mixture in patients with PHN.
METHODS/DESIGN: This study is a single-center, two-group (1:1), randomized, placebo-controlled, double-blind clinical trial. A total of 42 patients with postherpetic neuralgia will be recruited and randomly divided into the intervention group and the control group. The control group will receive routine treatment plus oxygen, and the intervention group will receive routine treatment plus nitrous oxide/oxygen mixture. Data collectors, patients, and clinicians are all blind to the therapy. The outcomes of each group will be monitored at baseline (T0), 5 min (T1), and 15 min (T2) after the start of the therapy and at 5 min after the end of the therapy (T3). The primary outcome measure will be the pain intensity. Secondary outcomes included physiological parameters, adverse effects, patients' acceptance of analgesia, and satisfaction from patients.
Previous studies have shown that nitrous oxide/oxygen mixture can effectively relieve cancer patients with breakthrough pain. This study will explore the analgesic effect of oxide/oxygen mixture on PHN. If beneficial to patients with PHN, it will contribute to the pain management of PHN.
Chinese Clinical Trial Register ChiCTR1900023730 . Registered on 9 June 2019.
带状疱疹后神经痛（PHN）的疼痛管理仍然是一个主要挑战，没有即时缓解。笑气/氧气混合物具有镇痛效果快和耐受性好的优点。本研究旨在探讨笑气/氧气混合物在 PHN 患者中的镇痛效果和安全性。
方法/设计：这是一项单中心、两臂（1:1）、随机、安慰剂对照、双盲临床试验。共招募 42 例 PHN 患者，随机分为干预组和对照组。对照组给予常规治疗加氧气，干预组给予常规治疗加笑气/氧气混合物。数据收集者、患者和临床医生均对治疗方案不知情。每组的结果将在基线（T0）、治疗开始后 5 分钟（T1）、15 分钟（T2）以及治疗结束后 5 分钟（T3）进行监测。主要结局指标为疼痛强度。次要结局指标包括生理参数、不良反应、患者对镇痛的接受程度和满意度。
先前的研究表明，笑气/氧气混合物可有效缓解癌症患者的爆发性疼痛。本研究将探讨笑气/氧气混合物对 PHN 的镇痛效果。如果对 PHN 患者有益，将有助于 PHN 的疼痛管理。
中国临床试验注册中心 ChiCTR1900023730。注册于 2019 年 6 月 9 日。
