Recruiting
Early Phase 1

Nitrous Oxide

Sponsor:

University of Manitoba

Code:

NCT03695887

Conditions

Burns

Pain, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nitrous Oxide Inhalant Product

Placebo

Study Details

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.

Conditions

Burns

Pain, Acute

Study ID

NCT03695887

Start date

Oct 1, 2019

Status verified date

May, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nitrous Oxide Inhalant Product

Nitrous oxide

placebo comparator: Placebo

placebo comparator

Interventions

Nitrous Oxide Inhalant Product

Nitrous Oxide Inhalant Product

Placebo

Inactive comparator

Primary outcome measure

  • Burn Specific Pain Anxiety Scale [ Time Frame: 1 hour before dressing change ]
  • Burn Specific Pain Anxiety Scale [ Time Frame: during dressing change ]
  • Burn Specific Pain Anxiety Scale [ Time Frame: 1 hour after dressing change ]
  • Visual Analogue Scale for pain [ Time Frame: 1 hour before dressing change ]
  • Visual Analogue Scale for pain [ Time Frame: during dressing change ]
  • Visual Analogue Scale for pain [ Time Frame: 1 hour after dressing change ]
  • Visual Analogue Scale for anxiety [ Time Frame: 1 hour before dressing change ]
  • Visual Analogue Scale for anxiety [ Time Frame: during dressing change ]
  • Visual Analogue Scale for anxiety [ Time Frame: 1 hour after dressing change ]

Central Contacts and Locations

Central contacts

Sarvesh Logsetty, MD

2047878682logsetty@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Justin P Gawaziuk, MSc

2047873669jgawaziuk@hsc.mb.ca

Principal Investigator:

Sarvesh Logsetty, MD

More Information

Sponsor

University of Manitoba

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • burns, pain, dressing change, nitrous oxide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-05-14.