Roelofse 1996b.

Methods	Parallel group RCT Location: South Africa Funding: not stated
Participants	Inclusion criteria: children ASA I aged 2 to 7 years old, requiring dental extraction under sedation n = 60 Gender, mean age (SD) in years: Group 1 (n = 30), 14 male, 16 female, 4.8 (1.3) Group 2 (n = 30), 16 male, 14 female, 4.9 (1.3)
Interventions	Group 1: 0.5 ml/kg of trimeprazine 6 mg/ml + physeptone (0.4 mg/ml) (SOP) Group 2: ketamine (12.5 mg/kg) All oral, administered by a member of the research team not the operator
Outcomes	Anxiety, level of sedation, movement, crying, overall behaviour
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Assigned randomly" ‐ method of sequence generation not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding ‐ Participant	Low risk	Study described as double‐blind
Blinding ‐ Operator/sedationist	Low risk	Quote: "both operator and assessor blind to treatment received"
Blinding ‐ Outcome assessor	Low risk	Quote: "both operator and assessor blind to treatment received"
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