Mercadante 2010.

Methods	Design: randomised, open label, parallel group study for control of breakthrough pain Duration: 4 weeks with extension up to 8 weeks Setting: outpatient or home care
Participants	Pancreatic cancer pain with PI ≥ 4/10, requiring opioids N = 60 randomised, but only 46 (M 19, F 27) completed baseline observations, 39 completed 4 weeks, 17 completed 8 weeks Mean age 63 years
Interventions	Mm/r 30 mg/day initially Oxycodone 20 mg/day initially Dose escalated according to clinical need (if PI > 4/10, or > 3 breakthrough pain medications per day) Adjuvant and symptomatic drugs prescribed as indicated Rescue medication: MIR at 1/6 total daily dose
Outcomes	Average PI in last 24 hours: NRS (0 ‐ 10) Opioid‐related symptoms: Nausea and vomiting, drowsiness and confusion (0 ‐ 3) Constipation rating scale (0 ‐ 3)
Notes	Oxford Quality Score: R = 1, DB = 0, W = 1. Total = 2/5
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"randomised by computer system"
Allocation concealment (selection bias)	Unclear risk	Method not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open label
Incomplete adverse event outcome data‐ patient level	Low risk	>90% participants included
Selective reporting bias for adverse events	High risk	Selective reporting. Mean symptom scores
Size	High risk	< 50 participants per treatment arm