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A comparison of 2 different medicated ointments with placebo for pain relief after banding of haemorrhoids.

Phase 3
Completed
Conditions
haemorrhoids
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Registration Number
ACTRN12620000044921
Lead Sponsor
Hunter New England Local Health District
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
99
Inclusion Criteria

Patients aged 18 years and over who present to the colorectal outpatient clinic or the private rooms of participating surgeons with symptomatic haemorrhoids suitable for banding will be considered for inclusion and offered study information.

Exclusion Criteria

A person will be excluded if they have the following:
• Coexisting anorectal disease such as anal fissure, fistula in ano, perianal abscess, thrombosed haemorrhoids, or colorectal malignancy
• A current medical history of uncontrolled ischemic heart disease, heart block, pregnancy or currently breastfeeding, severe hypertension (systolic blood pressure greater than 180mmHg), or orthostatic hypotension
• Poor general condition (i.e ASA classification 4 or 5)
• Allergy or sensitivity to diltiazem, lignocaine or polyethylene glycol (PEG) USP ointment base
• Current calcium channel blocker use
• Known side effects from previous calcium channel blocker use
• Refuse or are unable to give written informed consent to participate in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain scores between the 3 arms will be assessed using a standardised 10-point patient reported continuous visual analogue scale (zero represented no pain at all, and ten represented the severest pain imaginable)[• 30 minutes<br>• 1 hour<br>• 6 hours<br>• 12 hours<br>• 24 hours<br>• 48 hours]
Secondary Outcome Measures
NameTimeMethod
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