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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minute mark during burn dressing change
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
5-20% of my body has burn injuries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minute mark during burn dressing change
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minute mark during burn dressing change
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Burn Specific Pain Anxiety Scale
Anxiety
Visual Analogue Scale for pain
Secondary outcome measures
Anxiolytic given
Other outcome measures
Diastolic blood pressure
Heart rate
Systemic arterial pressure
+2 moreTrial 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
595 Previous Clinical Trials
199,496 Total Patients Enrolled
5 Trials studying Burns
57 Patients Enrolled for Burns
Sarvesh LogsettyPrincipal InvestigatorUniversity of Manitoba
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your oxygen level is below 90% when breathing normally.I am currently in the intensive care unit.I cannot physically hold a canister.I have burns on my face.You have been taking painkillers before getting injured (may not be allowed to participate).I cannot use nitrous oxide due to a serious heart or lung condition.5-20% of my body has burn injuries.I have a previous lung injury.Adults who have been admitted to the Health Sciences Centre for burn treatment.I have used IV ketamine.I am able to participate in tests and understand instructions.
Research Study Groups:
This trial has the following groups:- Group 1: Nitrous Oxide Inhalant Product
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any recorded precedents for Nitrous Oxide Inhalant Product trials?
"Presently, there are a dozen clinical trials evaluating the efficacy of Nitrous Oxide Inhalant Product. One is in Phase 3 while the rest are distributed among 12 centres situated mainly in Saint Louis, Missouri."
Answered by AI
What is the participant sample size of this clinical investigation?
"Affirmative. According to clinicaltrials.gov, this medical investigation is actively seeking volunteers for its research team. The trial was first posted on October 1st 2019 and then updated most recently on May 16th 2022; 30 patients are needed from a single site of recruitment."
Answered by AI
Are any openings available to join this research endeavor?
"Affirmative, the details on clinicaltrials.gov prove that this clinical trial is currently recruiting participants. This investigation was initialised on October 1st 2019 and updated most recently on May 16th 2022. 30 patients need to be sourced from a single medical site."
Answered by AI
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