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Trials
Published in: Trials 1/2021

Open Access 01-12-2021 | Analgesics in Dentistry | Study protocol

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

Authors: Hai-Xiang Gao, Jun-Jun Zhang, Ning Liu, Yi Wang, Chun-Xiang Ma, Lu-Lu Gao, Qiang Liu, Ting-Ting Zhang, Yi-Ling Wang, Wen-Qiang Bao, Yu-Xiang Li

Published in: Trials | Issue 1/2021

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Abstract

Background

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.

Discussion

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.

Trial registration

Chinese Clinical Trial Register ChiCTR1900023730​. Registered on 9 June 2019
Appendix
Available only for authorised users
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Metadata
Title
A fixed nitrous oxide/oxygen mixture as an analgesic for patients with postherpetic neuralgia: study protocol for a randomized controlled trial
Authors
Hai-Xiang Gao
Jun-Jun Zhang
Ning Liu
Yi Wang
Chun-Xiang Ma
Lu-Lu Gao
Qiang Liu
Ting-Ting Zhang
Yi-Ling Wang
Wen-Qiang Bao
Yu-Xiang Li
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04960-5

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