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

NCT03695887 | Recruiting Early Phase 1 DMC

• 1 other identifier: nitrousoxide
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Burns

Keywords

burns, pain, dressing change, nitrous oxide

Outcome Measures

Primary Outcomes (9)

• 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: 1. Worry about wound-healing 2. Fear of procedural pain 3. Fear of losing control because of pain 4. Fear of pain during dressing change 5. Pain severity 6. Keyed up because of enduring pain 7. Concern about wound healing 8. Preoccupied with pain 9. 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: 1. Worry about wound-healing 2. Fear of procedural pain 3. Fear of losing control because of pain 4. Fear of pain during dressing change 5. Pain severity 6. Keyed up because of enduring pain 7. Concern about wound healing 8. Preoccupied with pain 9. 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: 1. Worry about wound-healing 2. Fear of procedural pain 3. Fear of losing control because of pain 4. Fear of pain during dressing change 5. Pain severity 6. Keyed up because of enduring pain 7. Concern about wound healing 8. Preoccupied with pain 9. 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 Outcomes (3)

• Anxiolytic given

  1 hour before dressing change

• Anxiolytic given

  during dressing change

• Anxiolytic given

  1 hour after dressing change

Other Outcomes (20)

• Systolic blood pressure

  5 minute mark during burn dressing change

• Systolic blood pressure

  10 minute mark during burn dressing change

• Systolic blood pressure

  15 minute mark during burn dressing change

Study Arms (2)

Nitrous Oxide Inhalant Product

EXPERIMENTAL

Nitrous oxide

Drug: Nitrous Oxide Inhalant Product

Placebo

PLACEBO COMPARATOR

placebo comparator

Drug: Placebo

Interventions

Nitrous Oxide Inhalant Product DRUG

Nitrous Oxide Inhalant Product

Nitrous Oxide Inhalant Product

Placebo DRUG

Inactive comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult burn patients admitted to the Health Sciences Centre
• total body surface area burned of 5-20%

You may not qualify if:

• 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
• use of IV ketamine
• pre-existing lung injury

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 19016572 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.

  PMID: 22624697 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.

  PMID: 24495641 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.

  PMID: 10498356 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.

  PMID: 19108597 BACKGROUND

MeSH Terms

Conditions

Burns; Acute Pain; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarvesh Logsetty

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarvesh Logsetty, MD

CONTACT

2047878682; logsetty@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: October 1, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)