A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult burn patients admitted to the Health Sciences Centre
total body surface area burned of 5-20%
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Nitrous Oxide Inhalant Product
DrugNitrous Oxide Inhalant Product
Placebo
DrugInactive comparator
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Nitrous Oxide Inhalant ProductExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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: 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.
Time frame
1 hour before dressing change2
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: 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.
Time frame
during dressing change3
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: 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.
Time frame
1 hour after dressing change4
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").
Time frame
1 hour before dressing changeSecondary outcomes
1
Anxiolytic given
The amount of anxiolytic given one hour prior to the dressing change.
Time frame
1 hour before dressing change2
Anxiolytic given
The amount of anxiolytic given during the dressing change.
Time frame
during dressing change3
Anxiolytic given
The amount of anxiolytic given one hour after the dressing change.
Time frame
1 hour after dressing changeOther outcomes
1
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame
5 minute mark during burn dressing change2
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame
10 minute mark during burn dressing change3
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame
15 minute mark during burn dressing change4
Systolic blood pressure
After administration of inhaled nitrous oxide, systolic blood pressure will be measured.
Time frame
20 minute mark during burn dressing changeSponsors and contacts
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Source ClinicalTrials.gov