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

NCT ID: NCT03695887

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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The normal challenges of using narcotics are increased in burn patients, who have significantly altered metabolism. Unfortunately, the use of regular general anesthesia or conscious sedation is not a viable option due to the resources required, and as the hypermetabolism of burn injury would result in compromised wound healing with repeated periods of without eating related halting of nutritional intake. This has led to the use of a number of adjuncts ranging from nonmedical (virtual reality, mindfulness, hypnosis etc.) to medication (ketamine, anxiolytics etc.). Historically Nitrous oxide has been used in similar settings where severe procedural pain is of relatively shorter duration, such as tooth extraction, labor or minor surgical procedures. Nitrous oxide is a rapidly acting analgesic that takes effect seconds after inhalation, and lasts minutes. While a randomized trial of Nitrous oxide in burn care has been proposed, the only published information currently available is in a Chinese medical journal.

To address this a gap in knowledge, a pilot Randomized Controlled trial is proposed to evaluate if Nitrous Oxide in the form of limited dose inhaler canisters can be used to improve pain control during burn dressing changes compared to placebo canisters.

Conditions

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Burns Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nitrous Oxide Inhalant Product

Nitrous oxide

Group Type EXPERIMENTAL

Nitrous Oxide Inhalant Product

Intervention Type DRUG

Nitrous Oxide Inhalant Product

Placebo

placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive comparator

Interventions

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Nitrous Oxide Inhalant Product

Nitrous Oxide Inhalant Product

Intervention Type DRUG

Placebo

Inactive comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sarvesh Logsetty

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarvesh Logsetty

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sarvesh Logsetty, MD

Role: CONTACT

[email protected]
2047878682

Facility Contacts

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Justin P Gawaziuk, MSc

Role: primary

[email protected]
2047873669

References

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Gregoretti C, Decaroli D, Piacevoli Q, Mistretta A, Barzaghi N, Luxardo N, Tosetti I, Tedeschi L, Burbi L, Navalesi P, Azzeri F. Analgo-sedation of patients with burns outside the operating room. Drugs. 2008;68(17):2427-43. doi: 10.2165/0003495-200868170-00003.

Reference Type BACKGROUND
PMID: 19016572 (View on PubMed)

Yuxiang L, Lu T, Jianqiang Y, Xiuying D, Wanfang Z, Wannian Z, Xiaoyan H, Shichu X, Wen N, Xiuqiang M, Yinsheng W, Ming Y, Guoxia M, Guangyi W, Wenjun H, Zhaofan X, Hongtai T, Jijun Z. Analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain: study protocol for a randomized controlled trial. Trials. 2012 May 24;13:67. doi: 10.1186/1745-6215-13-67.

Reference Type BACKGROUND
PMID: 22624697 (View on PubMed)

Li YX, Tang HT, Zhou WF, Hu XY, Xiao SC, Niu XH, Li YC, Wu YS, Yao M, Wang HX, Xia ZF, Zhao JJ. [Analgesic and sedative effects of inhaling a mixture of nitrous oxide and oxygen on burn patient during and after dressing change]. Zhonghua Shao Shang Za Zhi. 2013 Dec;29(6):537-40. Chinese.

Reference Type BACKGROUND
PMID: 24495641 (View on PubMed)

Taal LA, Faber AW, van Loey NE, Reynders CL, Hofland HW. The abbreviated burn specific pain anxiety scale: a multicenter study. Burns. 1999 Sep;25(6):493-7. doi: 10.1016/s0305-4179(99)00034-0.

Reference Type BACKGROUND
PMID: 10498356 (View on PubMed)

Becker DE, Rosenberg M. Nitrous oxide and the inhalation anesthetics. Anesth Prog. 2008 Winter;55(4):124-30; quiz 131-2. doi: 10.2344/0003-3006-55.4.124.

Reference Type BACKGROUND
PMID: 19108597 (View on PubMed)

Other Identifiers

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nitrousoxide

Identifier Type: -

Identifier Source: org_study_id