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

Burns Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695887
• Other study ID #: nitrousoxide
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 1, 2019
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: Sarvesh Logsetty, MD
• Phone: 2047878682
• Email: logsetty[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Burns
• Pain, Acute

Intervention

Drug:
• Nitrous Oxide Inhalant Product
Nitrous Oxide Inhalant Product
• Placebo
Inactive comparator

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic blood pressure	After administration of inhaled nitrous oxide, systolic blood pressure will be measured.	5 minute mark during burn dressing change
Other	Systolic blood pressure	After administration of inhaled nitrous oxide, systolic blood pressure will be measured.	10 minute mark during burn dressing change
Other	Systolic blood pressure	After administration of inhaled nitrous oxide, systolic blood pressure will be measured.	15 minute mark during burn dressing change
Other	Systolic blood pressure	After administration of inhaled nitrous oxide, systolic blood pressure will be measured.	20 minute mark during burn dressing change
Other	Diastolic blood pressure	After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.	5 minute mark during burn dressing change
Other	Diastolic blood pressure	After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.	10 minute mark during burn dressing change
Other	Diastolic blood pressure	After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.	15 minute mark during burn dressing change
Other	Diastolic blood pressure	After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.	20 minute mark during burn dressing change
Other	Mean arterial pressure	After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.	5 minute mark during burn dressing change
Other	Mean arterial pressure	After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.	10 minute mark during burn dressing change
Other	Mean arterial pressure	After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.	15 minute mark during burn dressing change
Other	Mean arterial pressure	After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.	20 minute mark during burn dressing change
Other	Heart rate	After administration of inhaled nitrous oxide, heart rate will be measured.	5 minute mark during burn dressing change
Other	Heart rate	After administration of inhaled nitrous oxide, heart rate will be measured.	10 minute mark during burn dressing change
Other	Heart rate	After administration of inhaled nitrous oxide, heart rate will be measured.	15 minute mark during burn dressing change
Other	Heart rate	After administration of inhaled nitrous oxide, heart rate will be measured.	20 minute mark during burn dressing change
Other	Oxygen saturation	After administration of inhaled nitrous oxide, oxygen saturation will be measured.	5 minute mark during burn dressing change
Other	Oxygen saturation	After administration of inhaled nitrous oxide, oxygen saturation will be measured.	10 minute mark during burn dressing change
Other	Oxygen saturation	After administration of inhaled nitrous oxide, oxygen saturation will be measured.	15 minute mark during burn dressing change
Other	Oxygen saturation	After administration of inhaled nitrous oxide, oxygen saturation will be measured.	20 minute mark during burn dressing change
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Anxiolytic given	The amount of anxiolytic given one hour prior to the dressing change.	1 hour before dressing change
Secondary	Anxiolytic given	The amount of anxiolytic given during the dressing change.	during dressing change
Secondary	Anxiolytic given	The amount of anxiolytic given one hour after the dressing change.	1 hour after dressing change