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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous Oxide Inhalant Product | Experimental | Nitrous oxide |
|
| Placebo | Placebo Comparator | placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide Inhalant Product | Drug | Nitrous Oxide Inhalant Product |
| |
| 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:
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:
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:
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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | After administration of inhaled nitrous oxide, systolic blood pressure will be measured. | 5 minute mark during burn dressing change |
| Systolic blood pressure | After administration of inhaled nitrous oxide, systolic blood pressure will be measured. |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarvesh Logsetty, MD | Contact | 2047878682 | logsetty@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sarvesh Logsetty | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Recruiting | Winnipeg | Manitoba | R3A 1R9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19016572 | Background | 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. | |
| 22624697 | Background | 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. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D059787 | Acute Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
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| Placebo |
| Drug |
Inactive comparator |
|
| 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 |
| during dressing change |
| Anxiolytic given | The amount of anxiolytic given one hour after the dressing change. | 1 hour after dressing change |
| 10 minute mark during burn dressing change |
| Systolic blood pressure | After administration of inhaled nitrous oxide, systolic blood pressure will be measured. | 15 minute mark during burn dressing change |
| Systolic blood pressure | After administration of inhaled nitrous oxide, systolic blood pressure will be measured. | 20 minute mark during burn dressing change |
| Diastolic blood pressure | After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured. | 5 minute mark during burn dressing change |
| Diastolic blood pressure | After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured. | 10 minute mark during burn dressing change |
| Diastolic blood pressure | After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured. | 15 minute mark during burn dressing change |
| Diastolic blood pressure | After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured. | 20 minute mark during burn dressing change |
| Mean arterial pressure | After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured. | 5 minute mark during burn dressing change |
| Mean arterial pressure | After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured. | 10 minute mark during burn dressing change |
| Mean arterial pressure | After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured. | 15 minute mark during burn dressing change |
| Mean arterial pressure | After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured. | 20 minute mark during burn dressing change |
| Heart rate | After administration of inhaled nitrous oxide, heart rate will be measured. | 5 minute mark during burn dressing change |
| Heart rate | After administration of inhaled nitrous oxide, heart rate will be measured. | 10 minute mark during burn dressing change |
| Heart rate | After administration of inhaled nitrous oxide, heart rate will be measured. | 15 minute mark during burn dressing change |
| Heart rate | After administration of inhaled nitrous oxide, heart rate will be measured. | 20 minute mark during burn dressing change |
| Oxygen saturation | After administration of inhaled nitrous oxide, oxygen saturation will be measured. | 5 minute mark during burn dressing change |
| Oxygen saturation | After administration of inhaled nitrous oxide, oxygen saturation will be measured. | 10 minute mark during burn dressing change |
| Oxygen saturation | After administration of inhaled nitrous oxide, oxygen saturation will be measured. | 15 minute mark during burn dressing change |
| Oxygen saturation | After administration of inhaled nitrous oxide, oxygen saturation will be measured. | 20 minute mark during burn dressing change |
| 24495641 | Background | 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. |
| 10498356 | Background | 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. |
| 19108597 | Background | 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. |