Baygin 2010.
Methods | Parallel group RCT Location: Turkey Funding: not stated |
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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) |
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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 |
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Outcomes | Treatment completion, Ramsay Sedation Scale, Bispectral Index System, adverse effects | |
Notes | No placebo used 40% nitrous oxide all patients Sample size calculation given |
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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 |