Nitrous Oxide for Burn Pain Management

Overseen By Sarvesh Logsetty, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Manitoba

Must not be taking: Narcotics, IV ketamine

Disqualifiers: Respiratory disease, Cardiovascular disease, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of dressing change sessions

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that using IV ketamine or pre-injury narcotics might affect your eligibility. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment nitrous oxide for burn pain management?

Research shows that nitrous oxide, often called laughing gas, can help reduce pain and anxiety during burn dressing changes. It is effective when used alone or combined with other pain medications like fentanyl, making it a useful option for managing burn pain. ^{1 2 3 4 5}

Is nitrous oxide safe for use in humans?

Nitrous oxide has been used safely in medical settings for over a century, with few side effects and no significant adverse reactions reported in clinical use. However, misuse of nitrous oxide, especially in non-medical settings, can lead to serious health issues like nerve damage and mental impairment. ^{1 6 7 8 9}

How is nitrous oxide different from other drugs for burn pain management?

Nitrous oxide (laughing gas) is unique because it can be inhaled, providing quick pain relief and sedation without the need for general anesthesia, which is often required for burn dressing changes. It is easy to use, widely available, and can be self-administered, making it a flexible option compared to other pain management methods. ^{1 2 3 6 10}

What is the purpose of this trial?

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.

Research Team

Sarvesh Logsetty, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for adult burn patients with 5-20% of their body surface burned, not in intensive care, able to understand English and participate in outcome measurements. It excludes those with significant heart or lung disease, pregnant women, face burns, pre-injury narcotic use, ketamine treatment during the trial or a pre-existing lung injury.

Inclusion Criteria

5-20% of my body has burn injuries.

Adults who have been admitted to the Health Sciences Centre for burn treatment.

Exclusion Criteria

Your oxygen level is below 90% when breathing normally.

I am currently in the intensive care unit.

I cannot physically hold a canister.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nitrous oxide or placebo during burn dressing changes to evaluate pain control

Duration of dressing change sessions

Multiple visits for dressing changes

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 hour after each dressing change

Treatment Details

Interventions

• Nitrous Oxide Inhalant Product
• Placebo

Trial Overview The study tests if disposable nitrous oxide canisters provide effective pain relief during burn dressing changes compared to a placebo. The goal is to find an alternative to narcotics that avoids respiratory suppression while managing intense pain.

Participant Groups

Group I: Nitrous Oxide Inhalant Product Experimental Treatment 1 Intervention

Nitrous oxide

Group II: Placebo Placebo Group 1 Intervention

placebo comparator

Nitrous Oxide Inhalant Product is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nitrous Oxide for:

• Pain relief during medical procedures
• Anesthesia for dental and surgical procedures

Approved in European Union as Nitrous Oxide for:

• Pain relief during medical procedures
• Anesthesia for dental and surgical procedures

Approved in Canada as Nitrous Oxide for:

• Pain relief during medical procedures
• Anesthesia for dental and surgical procedures

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Findings from Research

In a study involving 15 adult burned patients, the combination of nitrous oxide (N2O) and fentanyl did not significantly reduce pain during dressing changes compared to using oxygen alone.

Patients reported similar pain levels and fentanyl consumption in both the N2O group and the control group, indicating that N2O did not provide additional analgesic benefits in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of nitrous oxide on fentanyl consumption in burned patients undergoing dressing change]. Vale, AH., Videira, RL., Gomez, DS., et al.[2016]

In a study involving 15 adult burned patients, the combination of nitrous oxide (N2O) and fentanyl did not significantly reduce pain during dressing changes compared to using oxygen alone.

Patients reported similar pain levels and fentanyl consumption in both the N2O group and the control group, indicating that N2O did not provide additional analgesic benefits in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nitrous oxide on fentanyl consumption in burned patients undergoing dressing change. do Vale, AH., Videira, RL., Gomez, DS., et al.[2017]

In a study of 70 stable adult burn patients, titrating nitrous oxide (N2O) from 30% to an ideal concentration significantly reduced pain and anxiety during burn dressing changes compared to a fixed 50% N2O treatment.

The titration method also resulted in minimal side effects and showed significant differences in vital signs, indicating a safer and more effective approach to pain management in burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of analgesic and anxiolytic effects of nitrous oxide in burn wound treatment: A single-blind prospective randomized controlled trial. Li, L., Pan, Q., Xu, L., et al.[2020]

Inhalation of a mixture of 65% nitrous oxide and oxygen significantly reduced pain and anxiety in burn patients during and after dressing changes, as evidenced by lower visual analogue scale (VAS) and burn specific pain anxiety scale (C-BSPAS) scores compared to the control group.

The treatment did not cause significant adverse effects and improved vital signs (heart rate, blood pressure, and oxygen saturation) during the procedure, indicating its safety and efficacy for managing discomfort in burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analgesic and sedative effects of inhaling a mixture of nitrous oxide and oxygen on burn patient during and after dressing change]. Li, YX., Tang, HT., Zhou, WF., et al.[2022]

Medical workers recognize a significant gap in effective pain management for children with burns during dressing changes, indicating a need for improvement in current practices.

After reviewing literature, medical staff expressed support for using 50% nitrous oxide as a pain management option for children, but they also noted that existing guidelines need to be updated to ensure its safe and effective application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical workers' cognition of using 50% nitrous oxide in children with burns: a qualitative study. Wang, HX., Li, YX., Zhou, RZ., et al.[2015]

Nitrous oxide (N2O) is a safe and effective anesthetic and analgesic gas that can be used in various medical situations due to its low incidence of adverse effects.

It can be administered by trained medical providers or even self-administered by patients, making it a versatile option in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on nitrous oxide and its use in anesthesia practice. Zafirova, Z., Sheehan, C., Hosseinian, L.[2019]

Nitrous oxide mixed with oxygen provides effective pain relief within 3 minutes and is successful in 75 to 81% of patients, making it a reliable option for managing procedure-related pain in children.

The nitrous oxide/oxygen mixture is considered safe with minimal side effects, and recent studies do not support concerns about diffusion hypoxia, reinforcing its suitability for pediatric use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analgesia using a (50/50) mixture of nitrous oxide/oxygen in children]. Carbajal, R.[2019]

Inhalation of nitrous oxide (N2O) from commercial sources, such as aerosol whipping cream containers and chargers, can lead to serious health risks including nerve damage, mental impairment, and even death due to hypoxemic mixtures.

The study found that these N2O products are highly concentrated and easily misused, suggesting a need for stricter regulations or discontinuation of their distribution due to their toxicity and lack of proper labeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrous oxide availability. Murray, MJ., Murray, WJ.[2019]

A systematic review of 34 studies on recreational nitrous oxide (N2O) use highlights a concerning increase in its use and associated harms, particularly among young people, yet there is a lack of awareness about these risks.

The review calls for improved harm reduction strategies, emphasizing the need for both policy changes and service delivery improvements to better address the growing issue of N2O use and its potential dangers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Recreational Nitrous Oxide Use: Implications for Policy, Service Delivery and Individuals. Allan, J., Cameron, J., Bruno, J.[2023]

The expert consensus outlines the safe and effective use of nitrous oxide and oxygen mixed inhalation for sedation and pain relief in burn surgery, based on insights from multiple expert meetings and practical experiences.

It includes comprehensive guidelines on indications, contraindications, potential side effects, and necessary training for healthcare providers to ensure optimal application of this sedation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Expert consensus on the application of nitrous oxide and oxygen mixed inhalation for sedation and analgesia technology in burn surgery (2021 version)]. [2021]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Effect of nitrous oxide on fentanyl consumption in burned patients undergoing dressing change]. [2016]

2. Brazil pubmed.ncbi.nlm.nih.gov

Effect of nitrous oxide on fentanyl consumption in burned patients undergoing dressing change. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of analgesic and anxiolytic effects of nitrous oxide in burn wound treatment: A single-blind prospective randomized controlled trial. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Analgesic and sedative effects of inhaling a mixture of nitrous oxide and oxygen on burn patient during and after dressing change]. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Medical workers' cognition of using 50% nitrous oxide in children with burns: a qualitative study. [2015]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Update on nitrous oxide and its use in anesthesia practice. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Analgesia using a (50/50) mixture of nitrous oxide/oxygen in children]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Nitrous oxide availability. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review of Recreational Nitrous Oxide Use: Implications for Policy, Service Delivery and Individuals. [2023]

10. China pubmed.ncbi.nlm.nih.gov

[Expert consensus on the application of nitrous oxide and oxygen mixed inhalation for sedation and analgesia technology in burn surgery (2021 version)]. [2021]