A Pilot Randomized Controlled Crossover Trial of the Effectiveness of Disposable Nitrous Oxide Canisters in Providing Improved Pain Control During Burn Dressing Changes.
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Burn Specific Pain Anxiety Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult burn patients admitted to the Health Sciences Centre
- •total body surface area burned of 5-20%
排除标准
- •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).
- •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
研究组 & 干预措施
Placebo
placebo comparator
干预措施: Placebo (Drug)
Nitrous Oxide Inhalant Product
Nitrous oxide
干预措施: Nitrous Oxide Inhalant Product (Drug)
结局指标
主要结局
Burn Specific Pain Anxiety Scale
时间窗: 1 hour after dressing change
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of: 1. Worry about wound-healing 2. Fear of procedural pain 3. Fear of losing control because of pain 4. Fear of pain during dressing change 5. Pain severity 6. Keyed up because of enduring pain 7. Concern about wound healing 8. Preoccupied with pain 9. Tension during dressing change Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Visual Analogue Scale for pain
时间窗: 1 hour after dressing change
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Visual Analogue Scale for anxiety
时间窗: 1 hour after dressing change
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Burn Specific Pain Anxiety Scale
时间窗: 1 hour before dressing change
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of: 1. Worry about wound-healing 2. Fear of procedural pain 3. Fear of losing control because of pain 4. Fear of pain during dressing change 5. Pain severity 6. Keyed up because of enduring pain 7. Concern about wound healing 8. Preoccupied with pain 9. Tension during dressing change Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Burn Specific Pain Anxiety Scale
时间窗: during dressing change
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of: 1. Worry about wound-healing 2. Fear of procedural pain 3. Fear of losing control because of pain 4. Fear of pain during dressing change 5. Pain severity 6. Keyed up because of enduring pain 7. Concern about wound healing 8. Preoccupied with pain 9. Tension during dressing change Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Visual Analogue Scale for pain
时间窗: 1 hour before dressing change
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Visual Analogue Scale for pain
时间窗: during dressing change
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Visual Analogue Scale for anxiety
时间窗: 1 hour before dressing change
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Visual Analogue Scale for anxiety
时间窗: during dressing change
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
次要结局
- Anxiolytic given(1 hour after dressing change)
- Anxiolytic given(1 hour before dressing change)
- Anxiolytic given(during dressing change)
研究者
Dr. Sarvesh Logsetty
Professor
University of Manitoba