None listed
Conditions
Brief summary
Pain is an expected problem after haemorrhoidectomy surgery and there have been a number of studies that have examined metronidazole in helping to reduce post-operative pain. The results are conflicting and the purpose of this study is to further examine the role of oral metronidazole plus standardised analgesia in reducing post-heamorrhoidectomy pain and compare its efficacy to placebo plus standardised analgesia.
Interventions
400mg oral metronidazole three times daily versus placebo for 7 days post-haemorrhoidectomy in addition to standard analgesic care for both groups.
Standard analgesic regimen is as follows; 1000mg oral paracetamol four times a day, 50mg diclofenac three times a day for 7-10 days, one macrogol 3350 13.8g sachet daily, oxycodone 5mg 6-hourly as required (20 tablets supplied).
No specific monitoring strategies regarding compliance for the intervention drug was established. Patients were counsell
400mg oral metronidazole three times daily versus placebo for 7 days post-haemorrhoidectomy in addition to standard analgesic care for both groups. Standard analgesic regimen is as follows; 1000mg oral paracetamol four times a day, 50mg diclofenac three times a day for 7-10 days, one macrogol 3350 13.8g sachet daily, oxycodone 5mg 6-hourly as required (20 tablets supplied). No specific monitoring strategies regarding compliance for the intervention drug was established. Patients were counselled to complete the course of trial medication as prescribed and also to report any potential side-effects. A list of common side-effects was included with the patient information and consent for and also contained within the trial questionnaire.
Sponsors
Bruce Wilkie
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Males and females between 18-70 years of age undergoing elective haemorrhoidectomy and able to provide voluntary consent for the procedure and to participate in the trial.
Exclusion criteria
Renal impairment (eGFR <50, severe ischemic heart disease, active peptic ulcer disease, alcoholism and IV opiate dependency, severe aspirin-sensitive asthma, pregnant women, institutionalised patients, patients unable to provide consent, patients with chronic pain conditions, hypersensitivity or known intolerance to metronidazole, NSAIDs or oxycodone.
Outcome results
None listed