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

• ClinicalTrials.gov Identifier: NCT03695887
• Recruitment Status: Recruiting
• First Posted: October 4, 2018
• Last Update Posted: May 17, 2021
• Sponsor: University of Manitoba
• Information provided by (Responsible Party): Dr. Sarvesh Logsetty, University of Manitoba

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.

Condition or disease	Intervention/treatment	Phase
Burns; Pain, Acute	Drug: Nitrous Oxide Inhalant Product; Drug: Placebo	Early Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized to receive either active study article or inactive comparator then crossed over to other treatment arm on next dressing change.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: October 1, 2019
• Estimated Primary Completion Date: December 1, 2021
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nitrous Oxide Inhalant Product; Nitrous oxide	Drug: Nitrous Oxide Inhalant Product; Nitrous Oxide Inhalant Product
Placebo Comparator: Placebo; placebo comparator	Drug: Placebo; Inactive comparator

Outcome Measures

Primary Outcome Measures :

1. Burn Specific Pain Anxiety Scale [ Time Frame: 1 hour before dressing change ]

   The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:

   1. Worry about wound-healing
   2. Fear of procedural pain
   3. Fear of losing control because of pain
   4. Fear of pain during dressing change
   5. Pain severity
   6. Keyed up because of enduring pain
   7. Concern about wound healing
   8. Preoccupied with pain
   9. 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.

2. Burn Specific Pain Anxiety Scale [ Time Frame: during dressing change ]

   The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:

   1. Worry about wound-healing
   2. Fear of procedural pain
   3. Fear of losing control because of pain
   4. Fear of pain during dressing change
   5. Pain severity
   6. Keyed up because of enduring pain
   7. Concern about wound healing
   8. Preoccupied with pain
   9. 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.

3. Burn Specific Pain Anxiety Scale [ Time Frame: 1 hour after dressing change ]

   The experience of the dressing change for the patient will also be assessed using the Burn specific pain and anxiety scale which consists of:

   1. Worry about wound-healing
   2. Fear of procedural pain
   3. Fear of losing control because of pain
   4. Fear of pain during dressing change
   5. Pain severity
   6. Keyed up because of enduring pain
   7. Concern about wound healing
   8. Preoccupied with pain
   9. 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.

4. Visual Analogue Scale for pain [ Time Frame: 1 hour before dressing change ]
   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").
5. Visual Analogue Scale for pain [ Time Frame: during dressing change ]
   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").
6. Visual Analogue Scale for pain [ Time Frame: 1 hour after dressing change ]
   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").
7. Visual Analogue Scale for anxiety [ Time Frame: 1 hour before dressing change ]
   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").
8. Visual Analogue Scale for anxiety [ Time Frame: during dressing change ]
   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").
9. Visual Analogue Scale for anxiety [ Time Frame: 1 hour after dressing change ]
   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 :

1. Anxiolytic given [ Time Frame: 1 hour before dressing change ]
   The amount of anxiolytic given one hour prior to the dressing change.
2. Anxiolytic given [ Time Frame: during dressing change ]
   The amount of anxiolytic given during the dressing change.
3. Anxiolytic given [ Time Frame: 1 hour after dressing change ]
   The amount of anxiolytic given one hour after the dressing change.

Other Outcome Measures:

1. Systolic blood pressure [ Time Frame: 5 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
2. Systolic blood pressure [ Time Frame: 10 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
3. Systolic blood pressure [ Time Frame: 15 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
4. Systolic blood pressure [ Time Frame: 20 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
5. Diastolic blood pressure [ Time Frame: 5 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
6. Diastolic blood pressure [ Time Frame: 10 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
7. Diastolic blood pressure [ Time Frame: 15 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
8. Diastolic blood pressure [ Time Frame: 20 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, Diastolic blood pressure will be measured.
9. Mean arterial pressure [ Time Frame: 5 minute mark during burn dressing change ]
   After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
10. Mean arterial pressure [ Time Frame: 10 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
11. Mean arterial pressure [ Time Frame: 15 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
12. Mean arterial pressure [ Time Frame: 20 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, mean arterial pressure (mmHg) will be measured.
13. Heart rate [ Time Frame: 5 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, heart rate will be measured.
14. Heart rate [ Time Frame: 10 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, heart rate will be measured.
15. Heart rate [ Time Frame: 15 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, heart rate will be measured.
16. Heart rate [ Time Frame: 20 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, heart rate will be measured.
17. Oxygen saturation [ Time Frame: 5 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, oxygen saturation will be measured.
18. Oxygen saturation [ Time Frame: 10 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, oxygen saturation will be measured.
19. Oxygen saturation [ Time Frame: 15 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, oxygen saturation will be measured.
20. Oxygen saturation [ Time Frame: 20 minute mark during burn dressing change ]
    After administration of inhaled nitrous oxide, oxygen saturation will be measured.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Sarvesh Logsetty, MD; 2047878682; logsetty@umanitoba.ca

Locations

Canada, Manitoba

University of Manitoba; Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contact: Justin P Gawaziuk, MSc 2047873669 jgawaziuk@hsc.mb.ca

Principal Investigator: Sarvesh Logsetty, MD

Sponsors and Collaborators

University of Manitoba

Investigators

• Principal Investigator: Sarvesh Logsetty; University of Manitoba

More Information

Publications:

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. Review.

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.

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.

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.

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. Review.

• Responsible Party: Dr. Sarvesh Logsetty, Professor, University of Manitoba
• ClinicalTrials.gov Identifier: NCT03695887
• Other Study ID Numbers: nitrousoxide
• First Posted: October 4, 2018
• Last Update Posted: May 17, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Sarvesh Logsetty, University of Manitoba:

burns, pain, dressing change, nitrous oxide

Additional relevant MeSH terms:

Acute Pain; Burns; Wounds and Injuries; Pain; Neurologic Manifestations; Nitrous Oxide; Anesthetics, Inhalation; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents