A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
- Conditions
- BurnsPain, Acute
- Interventions
- Drug: Nitrous Oxide Inhalant ProductDrug: Placebo
- Registration Number
- NCT03695887
- Lead Sponsor
- University of Manitoba
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nitrous Oxide Inhalant Product Nitrous Oxide Inhalant Product Nitrous oxide Placebo Placebo placebo comparator
- Primary Outcome Measures
Name Time Method Burn Specific Pain Anxiety Scale 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.Visual Analogue Scale for pain 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").
Visual Analogue Scale for anxiety 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
Name Time Method Anxiolytic given 1 hour after dressing change The amount of anxiolytic given one hour after the dressing change.
Trial Locations
- Locations (1)
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada