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Inhalational Analgesic

Nitrous Oxide for Burn Pain Management

Phase < 1
Recruiting
Led By Sarvesh Logsetty
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total body surface area burned of 5-20%
Be older than 18 years old
Must not have
Admitted to intensive care unit
Physically unable to hold the canister
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minute mark during burn dressing change

Summary

This trial is testing a new non-narcotic pain medication for people with burns.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Nitrous oxide may cause side effects like dizziness, nausea, headache or short-term disorientation. Long-term use can lead to vitamin B12 deficiency but this risk is low given the pilot nature of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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5-20% of my body has burn injuries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently in the intensive care unit.
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I cannot physically hold a canister.
Select...
I have burns on my face.
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I cannot use nitrous oxide due to a serious heart or lung condition.
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I have a previous lung injury.
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I have used IV ketamine.
Select...
I am able to participate in tests and understand instructions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minute mark during burn dressing change
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minute mark during burn dressing change for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Burn Specific Pain Anxiety Scale
Anxiety
Visual Analogue Scale for pain
Secondary study objectives
Anxiolytic given
Other study objectives
Diastolic blood pressure
Heart rate
Systemic arterial pressure
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitrous Oxide Inhalant ProductExperimental Treatment1 Intervention
Nitrous oxide
Group II: PlaceboPlacebo Group1 Intervention
placebo comparator

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
620 Previous Clinical Trials
206,751 Total Patients Enrolled
5 Trials studying Burns
57 Patients Enrolled for Burns
Sarvesh LogsettyPrincipal InvestigatorUniversity of Manitoba

Media Library

Nitrous Oxide Inhalant Product (Inhalational Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03695887 — Phase < 1
Burns Research Study Groups: Nitrous Oxide Inhalant Product, Placebo
Burns Clinical Trial 2023: Nitrous Oxide Inhalant Product Highlights & Side Effects. Trial Name: NCT03695887 — Phase < 1
Nitrous Oxide Inhalant Product (Inhalational Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03695887 — Phase < 1
~5 spots leftby Dec 2025
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