A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
追踪信息 | |||
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首次提交日期 ICMJE | October 2, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | December 1, 2018 | ||
预计主要完成日期 | December 1, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Burn Specific Pain Anxiety Scale[ Time Frame: Immediately after burn dressing change ] burn specific pain anxiety scale Visual Analogue Scale for pain[ Time Frame: Immediately after burn dressing change ] record pain on a scale Visual Analogue Scale for anxiety[ Time Frame: Immediately after burn dressing change ] record pain on a scale |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes | ||
正式标题 ICMJE | A Pilot Randomized Controlled Crossover Trial of the Effectiveness of Disposable Nitrous Oxide Canisters in Providing Improved Pain Control During Burn Dressing Changes. | ||
简要概况 | Improvements in burn care have resulted in increased survival. Despite these improved outcomes one of the leading challenges of burn care remains providing adequate analgesia during routine wound care and dressing changes. The traditional use of narcotics is challenging as the therapeutic window between analgesia and suppression of breathing becomes narrow with the intense pain and high doses of narcotics needed for dressing changes. The normal challenges of using narcotics are increased in burn patients, who have significantly altered metabolism. Unfortunately, the use of regular general anesthesia or conscious sedation is not a viable option due to the resources required, and as the hypermetabolism of burn injury would result in compromised wound healing with repeated periods of NPO related halting of nutritional intake. This has led to the use of a number of adjuncts ranging from nonmedical (virtual reality, mindfulness, hypnosis etc.) to medication (ketamine, anxiolytics etc.) 1. Historically Nitrous oxide has been used in similar settings where severe procedural pain is of relatively shorter duration, such as tooth extraction, labor or minor surgical procedures. Nitrous oxide is a rapidly acting analgesic that takes effect seconds after inhalation, and lasts minutes. While a randomized trial of Nitrous oxide in burn care has been proposed, the only published information currently available is in a Chinese medical journal. To address this gap in knowledge we propose a pilot Randomized Controlled trial to evaluate if Nitrous Oxide in the form of limited dose inhaler canisters can be used to improve pain control during burn dressing changes compared to placebo canisters. |
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详细说明 | The normal challenges of using narcotics are increased in burn patients, who have significantly altered metabolism. Unfortunately, the use of regular general anesthesia or conscious sedation is not a viable option due to the resources required, and as the hypermetabolism of burn injury would result in compromised wound healing with repeated periods of without eating related halting of nutritional intake. This has led to the use of a number of adjuncts ranging from nonmedical (virtual reality, mindfulness, hypnosis etc.) to medication (ketamine, anxiolytics etc.). Historically Nitrous oxide has been used in similar settings where severe procedural pain is of relatively shorter duration, such as tooth extraction, labor or minor surgical procedures. Nitrous oxide is a rapidly acting analgesic that takes effect seconds after inhalation, and lasts minutes. While a randomized trial of Nitrous oxide in burn care has been proposed, the only published information currently available is in a Chinese medical journal. To address this gap in knowledge we propose a pilot Randomized Controlled trial to evaluate if Nitrous Oxide in the form of limited dose inhaler canisters can be used to improve pain control during burn dressing changes compared to placebo canisters. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | Early Phase 1 | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Crossover Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
30 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | December 1, 2021 | ||
预计主要完成日期 | December 1, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - adult burn patients admitted to the Health Sciences Centre Exclusion Criteria: - intensive care unit admission for burn - cognitively impaired, unable to understand English, or visually impaired - medical condition that precludes using nitrous oxide. This includes persons with respiratory disease, and significant cardiovascular disease - individuals who may be pregnant, and those physically unable to hold the canister. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Canada | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Dr. Sarvesh Logsetty,University of Manitoba | ||
研究赞助商 ICMJE | University of Manitoba | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | University of Manitoba | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |