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A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Primary completion date: Dec 1, 2026 to Dec 1, 2028
    • Study completion date: Dec 1, 2027 to Dec 1, 2029
    v13
  3. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Dec 1, 2026 to Dec 1, 2027
    v12
  4. Primary completion date: Dec 1, 2023 to Dec 1, 2025
    • Study completion date: Dec 1, 2023 to Dec 1, 2026
    v11
  5. Primary completion date: Dec 1, 2021 to Dec 1, 2023
    • Study completion date: Dec 1, 2022 to Dec 1, 2023
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Site contact updatedv9
  2. Primary completion date: Dec 1, 2020 to Dec 1, 2021
    • Study completion date: Dec 1, 2021 to Dec 1, 2022
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Start date: May 1, 2019 to Oct 1, 2019v6
  5. Site contact updatedv5
  6. Start date: Jan 1, 2019 to May 1, 2019v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  8. Start date: Dec 1, 2018 to Jan 1, 2019v2 Show 5 more changesShow less
    • Primary endpoints: 3 to 9
    • Interventions: Nitrous Oxide Inhalant Product (Drug) to Nitrous Oxide Inhalant Product (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints expanded, about 6 words
    • Study description expanded, about 1 word
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03695887
Lead Sponsor University of Manitoba
Conditions
(from sponsor)		 Burns, Pain, Acute
Related terms Acute Pain, Burns, Pain
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov