Shanmugaavel 2016a.

Methods	Parallel design RCT Funding: not stated Location: India
Participants	Inclusion criteria: ASA 1 and 2. Venham's clinical anxiety scale score ≥ 3 during first visit and required treatment under local anaesthesia n = 20 Age range = 4 to 7 years Group 1 (n = 10) Group 2 (n = 10)
Interventions	Group 1: midazolam (0.2 mg/kg) (intranasal) Group 2: midazolam (0.2 mg/kg) (sublingual)
Outcomes	Venham's clinical anxiety scale, salivary cortisol level
Notes	Procedure was videotaped, restraints were used
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomization pattern generated by computer software"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding ‐ Participant	Unclear risk	Not described
Blinding ‐ Operator/sedationist	Low risk	Quote: "single operator blinded to routes of drug administration"
Blinding ‐ Outcome assessor	Unclear risk	Not described
Incomplete outcome assessment	High risk	Number of sedation failure not recorded
Free of selective reporting	Low risk	All planned outcomes reported
Free of other bias	High risk	Sample demographics not explained