An Early Phase 1 interventional study of Nitrous Oxide Inhalant Product and Placebo in Burns and Pain, Acute, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Manitoba · Early Phase 1, Interventional, and Treatment
Among 42 studies in Burns with a site in Canada — 14 open to participants now, 15 under way, 1 of them phase 3. Burns · Canada.
Among the 42 studies in Burns with a site in Canada, this one is the 18th largest by planned enrollment of the 36 interventional ones that give a count, is the only one that started in 2019, is one of 3 in phase 1, reaches primary completion later than 13 of the 14 other live ones, and was the 26th registered.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
Browse Burns studies →14 of the 42 studies in Burns with a site in Canada are open now. Recruiting first, the newest first:
Birch BioMed Inc · Sites in Canada
St. Justine's Hospital · Sites in Canada
University of Manitoba · Sites in Canada
University of Manitoba · Sites in Canada
CHU de Quebec-Universite Laval · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 9 · Phase 3 4 · Phase 4 3
First in 2005; this study’s year is marked. 1 started in 2019.
This study's planned enrollment of 30 is below the median of 40 across 663 interventional studies indexed under Burns.
Median enrollment 30 across the 36 interventional studies, 40 across the 5 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
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3 of 42 have an industry lead sponsor. The 10 most frequent:
University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
University of Manitoba has 7 studies filed under Burns — fewer than ten, so there is no comparison to draw.
2 of the studies in Burns with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06807021Phase 3Birch BioMed IncPost-Operative Use of FS2 to Mitigate Scarring in Burn Patients | 2027-09 |
| NCT07850557Centre hospitalier de l'Université de Montréal (CHUM)Hypertrophic Scar Prosthetic Pressure in Burn Amputee | 2026-12-31 |
Among the 42 studies in Burns with a site in Canada, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Nitrous oxide
Drug: Nitrous Oxide Inhalant Product
placebo comparator
Drug: Placebo
Nitrous Oxide Inhalant Product
Inactive comparator
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.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 1 hour after dressing change
Anxiolytic given
The amount of anxiolytic given one hour prior to the dressing change.
Time frame: 1 hour before dressing change
Anxiolytic given
The amount of anxiolytic given during the dressing change.
Time frame: during dressing change
Anxiolytic given
The amount of anxiolytic given one hour after the dressing change.
Time frame: 1 hour after dressing change
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame: 5 minute mark during burn dressing change
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame: 10 minute mark during burn dressing change
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame: 15 minute mark during burn dressing change
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame: 20 minute mark during burn dressing change
Diastolic blood pressure
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time frame: 5 minute mark during burn dressing change
Diastolic blood pressure
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time frame: 10 minute mark during burn dressing change
Diastolic blood pressure
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time frame: 15 minute mark during burn dressing change
Diastolic blood pressure
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time frame: 20 minute mark during burn dressing change
Mean arterial pressure
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time frame: 5 minute mark during burn dressing change
Mean arterial pressure
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time frame: 10 minute mark during burn dressing change
Mean arterial pressure
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time frame: 15 minute mark during burn dressing change
Mean arterial pressure
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time frame: 20 minute mark during burn dressing change
Heart rate
After administration of inhaled nitrous oxide, heart rate will be measured.
Time frame: 5 minute mark during burn dressing change
Heart rate
After administration of inhaled nitrous oxide, heart rate will be measured.
Time frame: 10 minute mark during burn dressing change
Heart rate
After administration of inhaled nitrous oxide, heart rate will be measured.
Time frame: 15 minute mark during burn dressing change
Heart rate
After administration of inhaled nitrous oxide, heart rate will be measured.
Time frame: 20 minute mark during burn dressing change
Oxygen saturation
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time frame: 5 minute mark during burn dressing change
Oxygen saturation
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time frame: 10 minute mark during burn dressing change
Oxygen saturation
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time frame: 15 minute mark during burn dressing change
Oxygen saturation
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time frame: 20 minute mark during burn dressing change
Plan to share: No
Started Oct 2019 (actual). Primary completion is estimated for Dec 2028, 110 months after the start.
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Studies of the drug tested here: Nitrous Oxide