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

nitrousoxide

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.

2019-10-01

2025-12-01

2026-12-01

Recruiting

Early phase I

30

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-11-29