None listed
Conditions
Brief summary
The purpose of this trial is test whether a new medication containing a plant based product MPPF, will reduce the amount of pain patients experience following an excisional haemorrhoidectomy. Evidence suggests there may be a reduction of pain following administration of oral MPPF, however there is no evidence to support the use of a topical formulation. We hypothesize that our cream will reduce the amount of pain patients report following excision of haemorrhoids, adding to a growing number of analgesic options for a very common problem seen worldwide.
Interventions
Intervention drug is a topical cream composed of 10% metronidazole (antibiotic), 4% lignocaine (local anaesthetic), and 5% micronized purified flavanoid fraction (MPFF). This will be taken for 1 week, three times per day. Applied morning following surgery.
The tubes will be collected and weighed to measure adherence at follow up.
The application of a topical cream composed of 10% metronidazole (antibiotic), 4% lignocaine
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult patients 18 years and over undergoing excisional haemorrhoidectomy of any type (open, closed) - Grade III or IV haemorrhoids - Willing and able to provide informed consent - Able to apply topical treatments independently
Exclusion criteria
- Patient’s <18 years - Haemorrhoids grade I or II - Concurrent perianal pathology – fissure, fistulas, ulcers etc - Known allergy or adverse drug reaction to metronidazole or lignocaine - Pregnant or breastfeeding women - Patients with history of chronic pain Patients unable to consent due to cognitive impairment or language barrier where an interpreter is unavailable
Outcome results
None listed