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

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合作者:
信息的提供 (责任方):
Dr. Sarvesh Logsetty,University of Manitoba
October 2, 2018
October 4, 2018
October 4, 2018
December 1, 2018
December 1, 2020   (主要结果测量的最终数据收集日期)
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

与当前相同
  • [ Time Frame: ]
 
A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
A Pilot Randomized Controlled Crossover Trial of the Effectiveness of Disposable Nitrous Oxide Canisters in Providing Improved Pain Control During Burn Dressing Changes.

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.

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.
Interventional
Early Phase 1
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
  • Drug: Nitrous Oxide Inhalant Product
    nitrous oxide inhalation
  • Experimental: Nitrous oxide
    active study article
  • Placebo Comparator: Placebo
    placebo comparator
 
Not yet recruiting
30
与当前相同
December 1, 2021
December 1, 2020   (主要结果测量的最终数据收集日期)
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.
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
Canada
 
No
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
计划分享 IPD: No
Dr. Sarvesh Logsetty,University of Manitoba
University of Manitoba
Principal Investigator: Sarvesh Logsetty University of Manitoba
University of Manitoba
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
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