NCT03695887 A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
| NCT ID | NCT03695887 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Manitoba |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2019-10-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sarvesh Logsetty
PRINCIPAL INVESTIGATOR
University of Manitoba
Frequently Asked Questions
Who can join the NCT03695887 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03695887 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03695887 currently recruiting?
Yes, NCT03695887 is actively recruiting participants. Contact the research team at logsetty@umanitoba.ca for enrollment information.
Where is the NCT03695887 trial being conducted?
This trial is being conducted at Winnipeg, Canada.
Who is sponsoring the NCT03695887 clinical trial?
NCT03695887 is sponsored by University of Manitoba. The principal investigator is Sarvesh Logsetty at University of Manitoba. The trial plans to enroll 30 participants.