The Use of Intranasal Fentanyl for the Treatment of Incident Dyspnea in Congestive Heart Failure: A Prospective Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- St. Boniface Hospital
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Walking distance from the 6MWT
Study Overview
Brief Summary
Study Objective The primary object of this study is to investigate the safety and effectiveness of fentanyl on the management of incident dyspnea.
Study Design The study design will be a cross over study with a minimum of a one hour wash out period.
Detailed Description
Clinical question and hypothesis In patients with congestive heart failure who experience episodic activity-induced dyspnea (incident dyspnea), will the administration of intranasal fentanyl pre-activity result in subjective improvement in dyspnea and objective improvement in functional capacity? Will there be side effects from this treatment?
We expect that pre-activity treatment with intranasal fentanyl will result in both subjective improvements in dyspnea ratings as well as an increased measurement of functional capacity. We also suspect that this treatment will not increase the patient's experienced side effects.
Study Objective The primary object of this study is to investigate the safety and effectiveness of fentanyl on the management of incident dyspnea.
Study Design The study design will be a cross over study with a minimum of a one hour wash out period.
Participation in this study will be for 2 hours over 1-2 days.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must be experiencing activity-induced incident dyspnea without reversible causes. They would have controlled background dyspnea without opioids.
- •Patients must be physically able to safely ambulate in order to complete the 6MWT (may have mobility devices and may use supplement oxygen prescribed pre-study).
Exclusion Criteria
- •Patients who are unable to perform the 6MWT for any reason or have contraindications to performing the 6MWT
- •Patients that have anatomical pathologies that would make intranasal administration impossible
- •Patients with known allergies/sensitivities to fentanyl/sufentanil
Arms & Interventions
Pre-fentanyl dose/fentanyl dose
Crossover: 6-six minute walk test, subjective rating of dyspnea, heart rate, respiratory rate, oxygen saturation and participants' general appearance measured before and after a dose of fentanyl.
Intervention: fentanyl (Drug)
Outcomes
Primary Outcomes
Walking distance from the 6MWT
Time Frame: 6 min
meters walked
Secondary Outcomes
- Subjective rating of dyspnea and side effects (Edmonton Symptom Assessment Scale)(Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min)
- respiratory rate(Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min)
- heart rate(Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min)
- oxygen saturation(Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min)
- general appearance (nurses subjective description)(Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min)
- blood pressure(Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min)
Investigators
Dr. Jana Pilkey
Physician
St. Boniface Hospital