Isik 2008b.

Methods	Parallel group RCT Location: Turkey Funding: not stated
Participants	Unco‐operative, Frankl scores 3, 4 Mean age (SD) in years, gender, mean weight (SD) in kg: Group 1 (n = 14), 4.6 (1.2), 7 males, 7 females, 15.6 (2.8) Group 2 (n = 13), 4.4 (1.0), 8 males, 5 females, 16.2 (2.4) Group 3 (n = 13), 4.4 (0.9), 6 males, 7 females, 16.1 (2.4) Group 4 (n = 13), 4.3 (0.9), 5 males, 8 females, 15.8 (2.6)
Interventions	Group 1: midazolam (0.2 mg/kg) Group 2: midazolam (0.5 mg/kg) Group 3: midazolam (0.75 mg/kg) Group 4: midazolam (1 mg/kg) All orally
Outcomes	Ramsay Sedation Score
Notes	40:60 nitrous oxide/oxygen given to all Translated from Turkish
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomized" ‐ method of sequence generation not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding ‐ Participant	Low risk	Subject blinded
Blinding ‐ Operator/sedationist	Low risk	Dentist blinded
Blinding ‐ Outcome assessor	Unclear risk	Separate outcome assessor, blinding unclear
Incomplete outcome assessment	Low risk	All patients evaluated
Free of selective reporting	Low risk	All planned outcomes reported
Free of other bias	Low risk	No other bias