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Trial details imported from ClinicalTrials.gov
Ethics application status
Prospective Evaluation of Pain Assessment and Management Protocol for Post-procedural Pain After Endoscopic Mucosal Resection of Colonic Polyps >20mm
Persistent Pain After Colonic Endoscopic Mucosal Resection: Predictors, a Management Algorithm and Outcomes
Universal Trial Number (UTN)
Endoscopic Mucosal Resection
Target follow-up duration
Description of intervention(s) / exposure
Post EMR - Patients are observed post EMR procedure for pain. Standard of care data is collected
Comparator / control treatment
Primary outcome 
Number of patients with EMR related pain post-procedurally - Patients are observed for pain post-procedurally and data collected on when/how pain is relieved
Secondary outcome 
Correlate post-procedural pain with procedural data - Identify if any patient or lesion factors are predictive of post EMR pain
Key inclusion criteria
- All patients referred to Westmead Hospital Endoscopy Unit to undergo an EMR of a
colonic lesion reported to be =20mm in size.
- Age =18 years.
- Patients able to give informed consent to involvement in the trial. For patients who
do not speak English, an interpreter will be asked to translate the informed consent.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Inability to sign informed consent.
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Westmead Hospital - Westmead
Recruitment postcode(s) 
Western Sydney Local Health District
Ethics application status
Endoscopic mucosal resection (EMR) of large (=20 mm) laterally spreading colonic lesions
(LSL) is safe, effective and superior to surgery. This advantage is based on a day stay model
of care, however the most common adverse event is abdominal pain and this is a major
impediment to this efficiency. No prospective data exist on the optimal selection of
analgesics, the necessary recovery period or the triggers that should alert the practitioner
to a more serious trajectory and the need for escalation of care.
We aimed to characterise potential predictors for persistent (>5 minutes) post-procedural
pain (PP) and develop a simple and effective management algorithm for patients with PP based
on the need for analgesics in recovery.
Data on consecutive patients with a LSL referred for EMR at a single, tertiary referral
centre were included. Patient and lesion characteristics and peri-procedural data were
prospectively collected. Standard post EMR care included 2 hours in first stage recovery
followed by 1 hour in 2nd stage recovery where clear fluids were given and discharge after if
the patients were well. PP was graded from 0 to 10 using a Visual Analogue Scale (VAS). If PP
occurred >5 minutes, 1 gram of paracetamol was administered parenterally and outcomes were
monitored. If pain settled the patient was transferred to second stage recovery after medical
review. PP >30 minutes lead to clinical review and upgrade of analgesics to fentanyl, with a
starting dose of 25 micrograms (mcg) up to a maximum of 100 mcg. Investigations, admission
and interventions for PP are recorded.
Trial related presentations / publications