Dale 2009.

Methods	Design: Randomised, double blind, two‐period cross‐over study. After titration of dose, participants randomised to receive either a single dose of MIR at bedtime followed by another dose 4 h later, or a double dose of MIR with a placebo dose 4 h later Duration: 2 x 1 night on each treatment Setting: hospital inpatients
Participants	Cancer pain N = 22 (19 completed) M 11, F 8 Mean age 57 years (45 ‐ 74)
Interventions	MIR single dose at bedtime and after 4 hours MIR double dose at bedtime and placebo after 4 hours
Outcomes	PI: 11‐point NRS Participant preference BPI, Edmonton symptom assessment scale
Notes	Oxford Quality Score: R = 2, DB = 2, W = 1. Total = 5/5
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"concealed procedure performed by hospital pharmacist using restricted randomisation table"
Allocation concealment (selection bias)	Low risk	"concealed procedure performed by hospital pharmacist using restricted randomisation table"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"placebo tablets identical in appearance and taste"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"placebo tablets identical in appearance and taste"
Incomplete adverse event outcome data‐ patient level	Unclear risk	Adverse events reported with patient numbers but not clear if everything was reported
Selective reporting bias for adverse events	Unclear risk	Only mean data with no denominator
Size	High risk	< 50 participants per treatment arm