A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes

Официальное название

A Pilot Randomized Controlled Crossover Trial of the Effectiveness of Disposable Nitrous Oxide Canisters in Providing Improved Pain Control During Burn Dressing Changes.

Обзор

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.

Подробное описание

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 a gap in knowledge, a pilot Randomized Controlled trial is proposed 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.

Вмешательства

• Препарат Nitrous Oxide Inhalant Product
  Nitrous Oxide Inhalant Product
• Препарат Placebo
  Inactive comparator

Первичные конечные точки

• Burn Specific Pain Anxiety Scale [Срок оценки: 1 hour before dressing change]
• Burn Specific Pain Anxiety Scale [Срок оценки: during dressing change]
• Burn Specific Pain Anxiety Scale [Срок оценки: 1 hour after dressing change]
• Visual Analogue Scale for pain [Срок оценки: 1 hour before dressing change]
• Visual Analogue Scale for pain [Срок оценки: during dressing change]
• Visual Analogue Scale for pain [Срок оценки: 1 hour after dressing change]
• Visual Analogue Scale for anxiety [Срок оценки: 1 hour before dressing change]
• Visual Analogue Scale for anxiety [Срок оценки: during dressing change]
• Visual Analogue Scale for anxiety [Срок оценки: 1 hour after dressing change]

Вторичные конечные точки (3)

• Anxiolytic given [Срок оценки: 1 hour before dressing change]
• Anxiolytic given [Срок оценки: during dressing change]
• Anxiolytic given [Срок оценки: 1 hour after dressing change]

Критерии участия

Критерии включения

• adult burn patients admitted to the Health Sciences Centre
• total body surface area burned of 5-20%

Критерии исключения

• admitted to intensive care unit
• unable to participate in the measurement outcomes (sedated, cognitively impaired, unable to understand English or visually impaired)
• medical condition that precludes using nitrous oxide (respiratory disease and significant cardiovascular disease 5).
• pregnant
• physically unable to hold the canister
• <90% SaO2 on room air
• face burn
• pre-injury narcotics (relative exclusion)
• use of IV ketamine
• pre-existing lung injury

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Manitoba — Winnipeg

Публикации

• Gregoretti C, Decaroli D, Piacevoli Q, Mistretta A, Barzaghi N, Luxardo N, Tosetti I, Tedeschi L, Burbi L, Navalesi P, Azzeri F. Analgo-sedation of patients with burns outside the operating room. Drugs. 2008;68(17):2427-43. doi: 10.2165/0003495-200868170-00003. PMID 19016572
• Yuxiang L, Lu T, Jianqiang Y, Xiuying D, Wanfang Z, Wannian Z, Xiaoyan H, Shichu X, Wen N, Xiuqiang M, Yinsheng W, Ming Y, Guoxia M, Guangyi W, Wenjun H, Zhaofan X, Hongtai T, Jijun Z. Analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain: study protocol for a randomized controlled trial. Trials. 2012 May 24;13:67. doi: 10.1186/1745-6215-13-67. PMID 22624697
• Li YX, Tang HT, Zhou WF, Hu XY, Xiao SC, Niu XH, Li YC, Wu YS, Yao M, Wang HX, Xia ZF, Zhao JJ. [Analgesic and sedative effects of inhaling a mixture of nitrous oxide and oxygen on burn patient during and after dressing change]. Zhonghua Shao Shang Za Zhi. 2013 Dec;29(6):537-40. Chinese. PMID 24495641
• Taal LA, Faber AW, van Loey NE, Reynders CL, Hofland HW. The abbreviated burn specific pain anxiety scale: a multicenter study. Burns. 1999 Sep;25(6):493-7. doi: 10.1016/s0305-4179(99)00034-0. PMID 10498356
• Becker DE, Rosenberg M. Nitrous oxide and the inhalation anesthetics. Anesth Prog. 2008 Winter;55(4):124-30; quiz 131-2. doi: 10.2344/0003-3006-55.4.124. PMID 19108597

Идентификаторы

NCT: NCT03695887 · nitrousoxide

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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