Clinical trial NCT03695887: A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
Official title: A Pilot Randomized Controlled Crossover Trial of the Effectiveness of Disposable Nitrous Oxide Canisters in Providing Improved Pain Control During Burn Dressing Changes.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Burns
Pain, Acute
Keywords: burns, pain, dressing change, nitrous oxide
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Burn Specific Pain Anxiety Scale
timeFrame: 1 hour before dressing change
measure: Burn Specific Pain Anxiety Scale
timeFrame: during dressing change
measure: Burn Specific Pain Anxiety Scale
timeFrame: 1 hour after dressing change
measure: Visual Analogue Scale for pain
timeFrame: 1 hour before dressing change
measure: Visual Analogue Scale for pain
timeFrame: during dressing change
measure: Visual Analogue Scale for pain
timeFrame: 1 hour after dressing change
measure: Visual Analogue Scale for anxiety
timeFrame: 1 hour before dressing change
measure: Visual Analogue Scale for anxiety
timeFrame: during dressing change
measure: Visual Analogue Scale for anxiety
timeFrame: 1 hour after dressing change
Secondary outcomes:
measure: Anxiolytic given
timeFrame: 1 hour before dressing change
measure: Anxiolytic given
timeFrame: during dressing change
measure: Anxiolytic given
timeFrame: 1 hour after dressing change
Other outcomes:
measure: Systolic blood pressure
timeFrame: 5 minute mark during burn dressing change
measure: Systolic blood pressure
timeFrame: 10 minute mark during burn dressing change
measure: Systolic blood pressure
timeFrame: 15 minute mark during burn dressing change
measure: Systolic blood pressure
timeFrame: 20 minute mark during burn dressing change
measure: Diastolic blood pressure
timeFrame: 5 minute mark during burn dressing change
measure: Diastolic blood pressure
timeFrame: 10 minute mark during burn dressing change
measure: Diastolic blood pressure
timeFrame: 15 minute mark during burn dressing change
measure: Diastolic blood pressure
timeFrame: 20 minute mark during burn dressing change
measure: Mean arterial pressure
timeFrame: 5 minute mark during burn dressing change
measure: Mean arterial pressure
timeFrame: 10 minute mark during burn dressing change
measure: Mean arterial pressure
timeFrame: 15 minute mark during burn dressing change
measure: Mean arterial pressure
timeFrame: 20 minute mark during burn dressing change
measure: Heart rate
timeFrame: 5 minute mark during burn dressing change
measure: Heart rate
timeFrame: 10 minute mark during burn dressing change
measure: Heart rate
timeFrame: 15 minute mark during burn dressing change
measure: Heart rate
timeFrame: 20 minute mark during burn dressing change
measure: Oxygen saturation
timeFrame: 5 minute mark during burn dressing change
measure: Oxygen saturation
timeFrame: 10 minute mark during burn dressing change
measure: Oxygen saturation
timeFrame: 15 minute mark during burn dressing change
measure: Oxygen saturation
timeFrame: 20 minute mark during burn dressing change
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Sarvesh Logsetty
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.