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. 2023 Oct 24;2023(10):CD014967. doi: 10.1002/14651858.CD014967.pub2

Risk of bias for analysis 6.3 Proportion of infants who develop sedation or drowsiness.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Solanki 2015 High risk of bias There is no information on allocation concealment and baseline characteristics suggest a mismatch between the two groups despite randomisation. Low risk of bias Though the personnel were aware of the intervention allocation, but there seems to be no deviations that arouse outside the trial context. Also all patients analysed as randomised. Low risk of bias Data reasonably complete for all the included patients Some concerns Since the outcome is a subjective one and that the assessors were aware of the intervention, there is a likelihood of assessment being influenced by the knowledge of the allocation group Low risk of bias Trial analysed as per a priori registered protocol. High risk of bias High risk in one domain