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NCT Number: NCT03695887

A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing 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.

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Key information

Conditions

Burns Acute Pain Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

Location status: Recruiting

Location contact

Justin P Gawaziuk, MSc

CONTACT

[email protected]

2047873669

Sarvesh Logsetty, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrous Oxide Inhalant Product

Drug

Nitrous Oxide Inhalant Product

Placebo

Drug

Inactive comparator

Primary outcomes

  1. 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:

    • 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.

  2. 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:

    • 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.

  3. 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:

    • 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.

  4. 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").

  5. 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").

  6. 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").

  7. 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").

  8. 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").

  9. 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").

Secondary outcomes

  1. Anxiolytic given

    Time frame: 1 hour before dressing change

    The amount of anxiolytic given one hour prior to the dressing change.

  2. Anxiolytic given

    Time frame: during dressing change

    The amount of anxiolytic given during the dressing change.

  3. Anxiolytic given

    Time frame: 1 hour after dressing change

    The amount of anxiolytic given one hour after the dressing change.

Other outcomes

  1. Systolic blood pressure

    Time frame: 5 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, systolic blood pressure will be measured.

  2. Systolic blood pressure

    Time frame: 10 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, systolic blood pressure will be measured.

  3. Systolic blood pressure

    Time frame: 15 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, systolic blood pressure will be measured.

  4. Systolic blood pressure

    Time frame: 20 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, systolic blood pressure will be measured.

  5. Diastolic blood pressure

    Time frame: 5 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.

  6. Diastolic blood pressure

    Time frame: 10 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.

  7. Diastolic blood pressure

    Time frame: 15 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.

  8. Diastolic blood pressure

    Time frame: 20 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.

  9. Mean arterial pressure

    Time frame: 5 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.

  10. Mean arterial pressure

    Time frame: 10 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.

  11. Mean arterial pressure

    Time frame: 15 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.

  12. Mean arterial pressure

    Time frame: 20 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.

  13. Heart rate

    Time frame: 5 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, heart rate will be measured.

  14. Heart rate

    Time frame: 10 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, heart rate will be measured.

  15. Heart rate

    Time frame: 15 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, heart rate will be measured.

  16. Heart rate

    Time frame: 20 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, heart rate will be measured.

  17. Oxygen saturation

    Time frame: 5 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, oxygen saturation will be measured.

  18. Oxygen saturation

    Time frame: 10 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, oxygen saturation will be measured.

  19. Oxygen saturation

    Time frame: 15 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, oxygen saturation will be measured.

  20. Oxygen saturation

    Time frame: 20 minute mark during burn dressing change

    After administration of inhaled nitrous oxide, oxygen saturation will be measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarvesh Logsetty, MD

CONTACT

[email protected]

2047878682

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2029
First posted
Oct 4, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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