About this trial
This project aims to evaluate the safety and efficacy of using a short-acting drug to reduce the maximal blood pressure during dangerous blood pressure spikes that happen during bowel care in individuals with spinal cord injury. the investigators will monitor the physiological effects of this drug during at-home bowel care to best understand the drug's effects in typical use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
participants must have had a traumatic spinal cord injury at least one year ago
regular bowel care routine
can communicate in English
Disqualifiers
cauda equina or conus lesions
currently use ventilator
colostomy, or do not perform regular bowel care
skin breakdown (pressure sores)
Trial design
Crossover
Treatments tested in this trial
Glyceryl Trinitrate Only Product in Oromucosal Dose Form
DrugGlyceryl trinitrate will be administered via sublingual spray.
Placebo sublingual spray
Other interventionA placebo sublingual spray will be administered.
Treatment groups
Trial outcomes
Primary outcomes
Blood pressure change during bowel care
Beat-to-beat blood pressure will be recorded using a finger blood pressure cuff (Finometer) on two occasions within 28 days, for up to one hour on each occasion.
Secondary outcomes
Change in symptoms of autonomic dysreflexia
Symptoms will be recorded after each arm of testing to determine if the drug condition improves symptoms
Incidence of arrhythmia
Beat-to-beat ECG will be recorded using a Finometer on two occasions within 28 days, for up to one hour on each occasion.
Locations
Sponsors and contacts
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Simon Fraser University
Lead sponsor
University of British Columbia
Collaborator
This trial is not recruiting at the moment. You can still explore other options: