A fixed nitrous oxide/oxygen mixture as an analgesic for patients with postherpetic neuralgia: study protocol for a randomized controlled trial

被引:3
作者
Gao, Hai-Xiang [1 ,2 ]
Zhang, Jun-Jun [1 ]
Liu, Ning [3 ]
Wang, Yi [4 ]
Ma, Chun-Xiang [4 ]
Gao, Lu-Lu [5 ]
Liu, Qiang [6 ]
Zhang, Ting-Ting [1 ]
Wang, Yi-Ling [1 ,7 ]
Bao, Wen-Qiang [4 ]
Li, Yu-Xiang [1 ]
机构
[1] Ningxia Med Univ, Sch Nursing, 1160 Sheng Li St, Yinchuan 750004, Ningxia, Peoples R China
[2] Second Peoples Hosp Yinchuan, Intens Care Unit, 684 Bei Jing St, Yinchuan 750011, Ningxia, Peoples R China
[3] Ningxia Med Univ, Dept Pharmacol, 1160 Sheng Li St, Yinchuan 750011, Ningxia, Peoples R China
[4] Ningxia Med Univ, Pain Dept, Gen Hosp, 804 Sheng Li St, Yinchuan 750004, Ningxia, Peoples R China
[5] Ningxia Med Univ, Sch Publ Hlth & Management, 1160 Sheng Li St, Yinchuan 750004, Ningxia, Peoples R China
[6] Ningxia Med Univ, Sch Preclin Med Sci, 1160 Sheng Li St, Yinchuan 750004, Ningxia, Peoples R China
[7] First Peoples Hosp Yinchuan, Dept Nursing, 2 Li Qun St, Yinchuan 750004, Ningxia, Peoples R China
关键词
Postherpetic neuralgia; Severe acute pain; Analgesia; Nitrous oxide; Randomized control trial;
D O I
10.1186/s13063-020-04960-5
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
BackgroundThe 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/designThis 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), 5min (T1), and 15min (T2) after the start of the therapy and at 5min 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.DiscussionPrevious 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.Trial registrationChinese Clinical Trial Register ChiCTR1900023730. Registered on 9 June 2019
引用
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页数:9
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