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

Baygin 2010.

Methods Parallel group RCT
Location: Turkey
Funding: not stated
Participants Unco‐operative (Frankl > 3)
n = 60 (n = 15 per group)
Gender, mean age (unclear, possibly SD) in years, mean weight (unclear, possibly SD) in kg:
Group 1 (n = 15), 10 males, 5 females, 5.33 (0.62), 18.93 (2.31)
Group 2 (n = 15), 11 males, 4 females, 5.27 (0.80), 19.07 (3.62)
Group 3 (n = 15), 9 males, 6 females, 5.20 (0.41), 18.20 (2.34)
Group 4 (n = 15), 6 males, 9 females, 5.53 (0.99), 20.01 (3.99)
Interventions Group 1: hydroxyzine (1 mg/kg) (oral) + 40% nitrous oxide oxygen
Group 2: midazolam (0.7 mg/kg) + 40% nitrous oxide oxygen
Group 3: ketamine (3 mg/kg) + midazolam (0.25 mg/kg) + 40% nitrous oxide oxygen
Group 4: 40% nitrous oxide oxygen
Outcomes Treatment completion, Ramsay Sedation Scale, Bispectral Index System, adverse effects
Notes No placebo used
40% nitrous oxide all patients
Sample size calculation given
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 Study drugs given by a trained nurse
Blinding ‐ Participant High risk Study described as being double‐blind, but no placebo used for group 4 who did not receive an oral medication
Blinding ‐ Operator/sedationist Low risk Study drugs administered by nurse and described as double‐blind
Blinding ‐ Outcome assessor Low risk One of the researchers who was blinded to the premedication drug evaluated every patient
Incomplete outcome assessment Low risk All patients evaluated
Free of selective reporting Low risk All planned outcomes reported
Free of other bias Low risk No other risks identified