A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
Primary Purpose
Burns, Pain, Acute
Status
Recruiting
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Nitrous Oxide Inhalant Product
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring burns, pain, dressing change, nitrous oxide
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
Sites / Locations
- University of ManitobaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nitrous Oxide Inhalant Product
Placebo
Arm Description
Nitrous oxide
placebo comparator
Outcomes
Primary Outcome Measures
Burn Specific Pain Anxiety Scale
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:
Worry about wound-healing
Fear of procedural pain
Fear of losing control because of pain
Fear of pain during dressing change
Pain severity
Keyed up because of enduring pain
Concern about wound healing
Preoccupied with pain
Tension during dressing change
Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Burn Specific Pain Anxiety Scale
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:
Worry about wound-healing
Fear of procedural pain
Fear of losing control because of pain
Fear of pain during dressing change
Pain severity
Keyed up because of enduring pain
Concern about wound healing
Preoccupied with pain
Tension during dressing change
Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Burn Specific Pain Anxiety Scale
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:
Worry about wound-healing
Fear of procedural pain
Fear of losing control because of pain
Fear of pain during dressing change
Pain severity
Keyed up because of enduring pain
Concern about wound healing
Preoccupied with pain
Tension during dressing change
Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Visual Analogue Scale for pain
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Visual Analogue Scale for pain
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Visual Analogue Scale for pain
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Visual Analogue Scale for anxiety
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Visual Analogue Scale for anxiety
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Visual Analogue Scale for anxiety
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Secondary Outcome Measures
Anxiolytic given
The amount of anxiolytic given one hour prior to the dressing change.
Anxiolytic given
The amount of anxiolytic given during the dressing change.
Anxiolytic given
The amount of anxiolytic given one hour after the dressing change.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03695887
Brief Title
A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
Official Title
A Pilot Randomized Controlled Crossover Trial of the Effectiveness of Disposable Nitrous Oxide Canisters in Providing Improved Pain Control During Burn Dressing Changes.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Pain, Acute
Keywords
burns, pain, dressing change, nitrous oxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitrous Oxide Inhalant Product
Arm Type
Experimental
Arm Description
Nitrous oxide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide Inhalant Product
Intervention Description
Nitrous Oxide Inhalant Product
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive comparator
Primary Outcome Measure Information:
Title
Burn Specific Pain Anxiety Scale
Description
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:
Worry about wound-healing
Fear of procedural pain
Fear of losing control because of pain
Fear of pain during dressing change
Pain severity
Keyed up because of enduring pain
Concern about wound healing
Preoccupied with pain
Tension during dressing change
Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Time Frame
1 hour before dressing change
Title
Burn Specific Pain Anxiety Scale
Description
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:
Worry about wound-healing
Fear of procedural pain
Fear of losing control because of pain
Fear of pain during dressing change
Pain severity
Keyed up because of enduring pain
Concern about wound healing
Preoccupied with pain
Tension during dressing change
Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Time Frame
during dressing change
Title
Burn Specific Pain Anxiety Scale
Description
The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:
Worry about wound-healing
Fear of procedural pain
Fear of losing control because of pain
Fear of pain during dressing change
Pain severity
Keyed up because of enduring pain
Concern about wound healing
Preoccupied with pain
Tension during dressing change
Responses for each item are on a visual analogue scale ranging from "least" to "most". The response is normalized to a value between 0 and 1, representing the location selected on the line, divided by the total length of the line. The responses will be used to examine a possible relationship procedural and non procedural pain between the nurse and the patient.
Time Frame
1 hour after dressing change
Title
Visual Analogue Scale for pain
Description
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Time Frame
1 hour before dressing change
Title
Visual Analogue Scale for pain
Description
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Time Frame
during dressing change
Title
Visual Analogue Scale for pain
Description
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("No pain") and 100 ("worst possible pain").
Time Frame
1 hour after dressing change
Title
Visual Analogue Scale for anxiety
Description
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Time Frame
1 hour before dressing change
Title
Visual Analogue Scale for anxiety
Description
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Time Frame
during dressing change
Title
Visual Analogue Scale for anxiety
Description
The items are scored on a 100 mm visual analog line with two reference points given values of 0 ("no anxiety") and 100 ("worst possible anxiety").
Time Frame
1 hour after dressing change
Secondary Outcome Measure Information:
Title
Anxiolytic given
Description
The amount of anxiolytic given one hour prior to the dressing change.
Time Frame
1 hour before dressing change
Title
Anxiolytic given
Description
The amount of anxiolytic given during the dressing change.
Time Frame
during dressing change
Title
Anxiolytic given
Description
The amount of anxiolytic given one hour after the dressing change.
Time Frame
1 hour after dressing change
Other Pre-specified Outcome Measures:
Title
Systolic blood pressure
Description
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time Frame
5 minute mark during burn dressing change
Title
Systolic blood pressure
Description
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time Frame
10 minute mark during burn dressing change
Title
Systolic blood pressure
Description
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time Frame
15 minute mark during burn dressing change
Title
Systolic blood pressure
Description
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time Frame
20 minute mark during burn dressing change
Title
Diastolic blood pressure
Description
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time Frame
5 minute mark during burn dressing change
Title
Diastolic blood pressure
Description
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time Frame
10 minute mark during burn dressing change
Title
Diastolic blood pressure
Description
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time Frame
15 minute mark during burn dressing change
Title
Diastolic blood pressure
Description
After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
Time Frame
20 minute mark during burn dressing change
Title
Mean arterial pressure
Description
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time Frame
5 minute mark during burn dressing change
Title
Mean arterial pressure
Description
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time Frame
10 minute mark during burn dressing change
Title
Mean arterial pressure
Description
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time Frame
15 minute mark during burn dressing change
Title
Mean arterial pressure
Description
After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
Time Frame
20 minute mark during burn dressing change
Title
Heart rate
Description
After administration of inhaled nitrous oxide, heart rate will be measured.
Time Frame
5 minute mark during burn dressing change
Title
Heart rate
Description
After administration of inhaled nitrous oxide, heart rate will be measured.
Time Frame
10 minute mark during burn dressing change
Title
Heart rate
Description
After administration of inhaled nitrous oxide, heart rate will be measured.
Time Frame
15 minute mark during burn dressing change
Title
Heart rate
Description
After administration of inhaled nitrous oxide, heart rate will be measured.
Time Frame
20 minute mark during burn dressing change
Title
Oxygen saturation
Description
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time Frame
5 minute mark during burn dressing change
Title
Oxygen saturation
Description
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time Frame
10 minute mark during burn dressing change
Title
Oxygen saturation
Description
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time Frame
15 minute mark during burn dressing change
Title
Oxygen saturation
Description
After administration of inhaled nitrous oxide, oxygen saturation will be measured.
Time Frame
20 minute mark during burn dressing change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarvesh Logsetty, MD
Phone
2047878682
Email
logsetty@umanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarvesh Logsetty
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin P Gawaziuk, MSc
Phone
2047873669
Email
jgawaziuk@hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Sarvesh Logsetty, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19016572
Citation
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.
Results Reference
background
PubMed Identifier
22624697
Citation
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.
Results Reference
background
PubMed Identifier
24495641
Citation
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.
Results Reference
background
PubMed Identifier
10498356
Citation
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.
Results Reference
background
PubMed Identifier
19108597
Citation
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.
Results Reference
background
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A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
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