Niu 2018.
Study characteristics | ||
Methods | RCT | |
Participants |
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Interventions | Intervention: sedative ( Comparison 6)
Comparator: placebo
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Outcomes | Nausea and vomiting | |
Notes | Setting: Aviation General Hospital, Beijing, China Dates: October 2016 to February 2017 Funding source: not reported Declaration of interest: stated that authors have no conflicts of interest Authors also reported on maternal pain and neonatal behavioral neurological assessment (NBNA), reporting no difference between the groups |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "random number generator" |
Allocation concealment (selection bias) | Unclear risk | Quote: “Allocated using random number by research fellow A 1:1 ratio – who was not involved with assessment or pt instructions (that was RF B). After obtaining consent, patients were allocated to either the propofol or the placebo group by opening a sealed opaque envelope.” However, it is unclear if the envelopes were sequentially numbered. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The parturient head site was covered by surgical drapes during the operation so they could not see the infusion line.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessed by independent Research Fellow that was not involved with randomisation – different research fellows assessed different outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All included in the analysis. 92 women were scheduled for CS – 12 were excluded, the remaining 80 women completed the trial |
Selective reporting (reporting bias) | Unclear risk | All outcomes from the methods section were reported on but we did not assess the trial protocol.. |
Other bias | Unclear risk | It is not clear if there may have been other biases |