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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burns; Pain, Acute
• Intervention / Treatment: Drug: Nitrous Oxide Inhalant Product; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sarvesh Logsetty, MD; Phone Number: 2047878682; Email: logsetty@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Recruiting
      • University of Manitoba
      • Contact: Justin P Gawaziuk, MSc; Phone Number: 2047873669; Email: jgawaziuk@hsc.mb.ca
      • Principal Investigator: Sarvesh Logsetty, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo comparator	Drug: Placebo; Inactive comparator
Experimental: Nitrous Oxide Inhalant Product; Nitrous oxide	Drug: Nitrous Oxide Inhalant Product; Nitrous Oxide Inhalant Product

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Sarvesh Logsetty, University of Manitoba

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: burns, pain, dressing change, nitrous oxide
• Additional Relevant MeSH Terms: Neurologic Manifestations; Wounds and Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Acute Pain; Burns; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anesthetics, General; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: nitrousoxide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No