McKee 1990.
Methods | Parallel group RCT Location: USA Funding: not stated |
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Participants | Inclusion criteria: healthy children 2 to 5 years old, Frankl scale behaviour negative or definitely negative, failed non‐pharma management, requiring restorative treatment with LA and rotary instrument
n = 60 Mean age (SE) in months: Group 1 (n = 15), 36.5 (2.7) Group 2 (n = 15), 41.7 (3) Group 3 (n = 15), 35.9 (2.7) Group 4 (n = 15), 43 ( 2.7) |
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Interventions | Group 1: placebo Group 2: meperidine (0.25 mg/lb) (approximately 0.11 mg/kg) Group 3: meperidine (0.50 mg/lb) (approximately 0.22 mg/kg) Group 4: meperidine (1 mg/lb) (approximately 0.45 mg/kg) All intramuscular, administered by "third party" | |
Outcomes | Modified Houpt, dichotomous behaviour scale, 10‐point behaviour scale, global rating scale, adverse effects | |
Notes | ||
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 | Low risk | Quote: "Dentist, patient and research observer were unaware of treatment allocation" |
Blinding ‐ Operator/sedationist | Low risk | Quote: "Dentist, patient and research observer were unaware of treatment allocation" |
Blinding ‐ Outcome assessor | Low risk | Quote: "Dentist, patient and research observer were unaware of treatment allocation" |
Incomplete outcome assessment | Low risk | Dropouts/aborted patients reported |
Free of selective reporting | Low risk | All planned outcomes reported |
Free of other bias | Low risk | No apparent differences between groups at baseline |