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. 2018 Dec 17;2018(12):CD003877. doi: 10.1002/14651858.CD003877.pub5

McKee 1990.

Methods Parallel group RCT
Location: USA
Funding: not stated
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)
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