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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Burns, Pain, Acute

Intervention / Treatment
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* Drug: Nitrous Oxide Inhalant Product
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria adult burn patients admitted to the Health Sciences Centre total body surface area burned of 5-20% Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrous Oxide Inhalant Product<br>Nitrous oxide | Drug: Nitrous Oxide Inhalant Product<br>* Nitrous Oxide Inhalant Product<br>|
| Placebo Comparator: Placebo<br>placebo comparator | Drug: Placebo<br>* Inactive comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burn Specific Pain Anxiety Scale | The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of: Worry about wound-healing Fear of procedural pain Fear of losing control because of pain Fear of pain during dressing change Pain severity Keyed up because of enduring pain Concern about wound healing Preoccupied with pain 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. | 1 hour before dressing change | 
| Burn Specific Pain Anxiety Scale | The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of: Worry about wound-healing Fear of procedural pain Fear of losing control because of pain Fear of pain during dressing change Pain severity Keyed up because of enduring pain Concern about wound healing Preoccupied with pain 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. | during dressing change | 
| Burn Specific Pain Anxiety Scale | The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of: Worry about wound-healing Fear of procedural pain Fear of losing control because of pain Fear of pain during dressing change Pain severity Keyed up because of enduring pain Concern about wound healing Preoccupied with pain 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. | 1 hour after dressing change | 
| Visual Analogue Scale for pain | 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). | 1 hour before dressing change | 
| Visual Analogue Scale for pain | 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). | during dressing change | 
| Visual Analogue Scale for pain | 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). | 1 hour after dressing change | 
| Visual Analogue Scale for anxiety | 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). | 1 hour before dressing change | 
| Visual Analogue Scale for anxiety | 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). | during dressing change | 
| Visual Analogue Scale for anxiety | 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). | 1 hour after dressing change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiolytic given | The amount of anxiolytic given one hour prior to the dressing change. | 1 hour before dressing change | 
| Anxiolytic given | The amount of anxiolytic given during the dressing change. | during dressing change | 
| Anxiolytic given | The amount of anxiolytic given one hour after the dressing change. | 1 hour after dressing change | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns, pain, dressing change, nitrous oxide