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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.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03695887
Enrollment
30
Registered
2018-10-04
Start date
2019-10-01
Completion date
2029-12-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Pain, Acute

Keywords

burns, pain, dressing change, nitrous oxide

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.

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.

Interventions

DRUGNitrous Oxide Inhalant Product

Nitrous Oxide Inhalant Product

DRUGPlacebo

Inactive comparator

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Burn Specific Pain Anxiety Scale1 hour before dressing changeThe 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 pain1 hour before dressing changeThe 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 anxiety1 hour before dressing changeThe 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").

Secondary

MeasureTime frameDescription
Anxiolytic given1 hour before dressing changeThe amount of anxiolytic given one hour prior to the dressing change.

Countries

Canada

Contacts

CONTACTSarvesh Logsetty, MD
logsetty@umanitoba.ca2047878682
PRINCIPAL_INVESTIGATORSarvesh Logsetty

University of Manitoba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026