BurnsEarly Phase 1NCT03695887
A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
A Early Phase 1 study testing Nitrous Oxide Inhalant Product in people with Burns and Pain, Acute, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Pain, Acute
- What is being tested?
- Nitrous Oxide Inhalant Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 1 Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult burn patients admitted to the Health Sciences Centre
- total body surface area burned of 5-20%
Who cannot join
- 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
Show all 10Show fewer
- face burn
- pre-injury narcotics (relative exclusion)
- use of IV ketamine
- pre-existing lung injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3A 1R9
Justin P Gawaziuk, MSc, 2047873669, jgawaziuk@hsc.mb.ca
Sarvesh Logsetty, MD
About this study
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.
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.
Read the 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.
- Conditions
- Burns, Pain, Acute
- Being tested
- Nitrous Oxide Inhalant Product, Placebo
- Keywords
- burns, pain, dressing change, nitrous oxide
- Medical subject headings
- Burns, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous Oxide Inhalant ProductDrug
Nitrous Oxide Inhalant Product
PlaceboDrug
Inactive comparator
| Study group | Role | What they receive |
|---|---|---|
| Nitrous Oxide Inhalant Product | Experimental | Nitrous oxide Receives: Drug: Nitrous Oxide Inhalant Product |
| Placebo | Placebo comparator | placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 1 hour after dressing change
Secondary outcomes (3)
Anxiolytic given
The amount of anxiolytic given one hour prior to the dressing change.
Measured: 1 hour before dressing change
Anxiolytic given
The amount of anxiolytic given during the dressing change.
Measured: during dressing change
Anxiolytic given
The amount of anxiolytic given one hour after the dressing change.
Measured: 1 hour after dressing change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Oct 2019
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sarvesh Logsetty, University of Manitoba
- Investigators
- Sarvesh Logsetty, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695887
- Sponsor's protocol ID
- nitrousoxide
- Status last verified
- May 2026
- First submitted
- 2 Oct 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19016572Yuxiang 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.
PubMed 22624697Li 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.
PubMed 24495641Taal 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.
PubMed 10498356Becker 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.
PubMed 19108597
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03695887
- Acronym / sponsor ID
- nitrousoxide
- Conditions
- Burns, Pain, Acute
- Keywords
- burns, pain, dressing change, nitrous oxide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
| Arm | Type | Receives |
|---|---|---|
| Nitrous Oxide Inhalant Product | Experimental | Drug: Nitrous Oxide Inhalant ProductNitrous oxide |
| Placebo | Placebo comparator | Drug: Placeboplacebo comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult burn patients admitted to the Health Sciences Centre
- total body surface area burned of 5-20%
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous Oxide Inhalant ProductNitrous Oxide Inhalant Product | Drug | Nitrous Oxide Inhalant Product |
| PlaceboInactive comparator | Drug | Placebo |
Primary outcome
Burn Specific Pain Anxiety Scale
Time frame: 1 hour before dressing change
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.
Burn Specific Pain Anxiety Scale
Time frame: during dressing change
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.
Burn Specific Pain Anxiety Scale
Time frame: 1 hour after dressing change
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.
Visual Analogue Scale for pain
Time frame: 1 hour before dressing change
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").
Visual Analogue Scale for pain
Time frame: during dressing change
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").
Visual Analogue Scale for pain
Time frame: 1 hour after dressing change
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").
Visual Analogue Scale for anxiety
Time frame: 1 hour before dressing change
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").
Visual Analogue Scale for anxiety
Time frame: during dressing change
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").
Visual Analogue Scale for anxiety
Time frame: 1 hour after dressing change
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").
3 secondary outcomes
Anxiolytic given
Time frame: 1 hour before dressing change
Anxiolytic given
Time frame: during dressing change
Anxiolytic given
Time frame: 1 hour after dressing change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 19016572Gregoretti 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.
- Background: PubMed 22624697Yuxiang 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.
- Background: PubMed 24495641Li 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.
- Background: PubMed 10498356Taal 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.
- Background: PubMed 19108597Becker 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.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarvesh Logsetty principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nitrous Oxide Inhalant Product in people with Burns and Pain, Acute, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarvesh Logsetty, MD (2047878682, logsetty@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burn Specific Pain Anxiety Scale (time frame: 1 hour before dressing change). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695887, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.