Aydintug 2004.

Methods	Parallel group RCT Location: Turkey Funding: not stated
Participants	Unco‐operative (Frankl) n = 50 Gender, mean age (unclear, possibly SD) in years, mean weight (unclear, possibly SD) in kg: Group 1 (n = 25), 18 males, 7 females, 5.36 (1.7), 19.068 (3.43) Group 2 (n = 25), 12 males, 13 females, 4.96 (1.513), 17.804 (3.08)
Interventions	Group 1: midazolam (0.5 mg/kg) (orally) Group 2: midazolam (0.35 mg/kg) (rectal)
Outcomes	Ramsay Sedation Score, acceptance of local anaesthetic, acceptance of sedation, operating conditions
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomly chosen" ‐ method of sequence generation not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding ‐ Participant	High risk	No blinding
Blinding ‐ Operator/sedationist	High risk	No blinding
Blinding ‐ Outcome assessor	High risk	No blinding
Incomplete outcome assessment	High risk	Numbers evaluated not stated
Free of selective reporting	Low risk	All planned outcomes reported
Free of other bias	Low risk	No apparent differences between groups at baseline