Lam 2005.

Methods	Parallel group RCT Location: USA Funding: not stated
Participants	Inclusion criteria: healthy ASA I children with severe caries involving 2 or more quadrants, very anxious, unlikely to tolerate treatment with or without N2O, requiring IV sedation. Unco‐operative (no index used) n = 23, 15 males, 7 females Mean age (range) in years: 5.13 (2‐9) Mean weight (range) in kg: 21.74 (12‐30)
Interventions	Group 1 (n = 12): midazolam (0.2 mg/kg) (intramuscular) Group 2 (n = 11): midazolam (0.2 mg/kg) (intranasal) All used as premedication for unspecified IV sedation drug. Drug administered by anaesthetist
Outcomes	Houpt
Notes	50% nitrous oxide all patients and papoose board
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomly assigned" ‐ method of sequence generation not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding ‐ Participant	High risk	Not possible
Blinding ‐ Operator/sedationist	High risk	Not blinded
Blinding ‐ Outcome assessor	Low risk	Quote: "evaluators had no prior knowledge of which premedication route had been used"
Incomplete outcome assessment	High risk	Numbers evaluated unclear
Free of selective reporting	Low risk	All planned outcomes reported
Free of other bias	High risk	No characteristics of the groups at baseline are reported