Charuluxananan 2003.
Study characteristics | ||
Methods | RCT | |
Participants | 240 ASA 1‐2 women undergoing CS under spinal anaesthesia without allergy to study drugs, pruritis, skin disease. | |
Interventions | Intervention 1: opioid antagonist (Comparison 7)
Intervention 2: 5‐HT3antagonist (Comparson 1)
Intervention 3: 5‐HT3antagonist (Comparson 1)
Comparator: placebo.
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Outcomes | Pruritis, post‐op nausea and vomiting, adverse effects. | |
Notes | Setting: King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Dates: not reported Funding source: not reported Declaration of interest: not reported In Comparison 1, data in Groups 2 and 3 were entered as subgroups and combined with overall data for treatment effect with the required adjustment of the placebo data for the 2 subgroups according to our methods (Unit of analysis issues) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes and randomly allocated coded syringes were prepared by a nurse anaesthetist not involved with the study |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote:"double blind" but not specifically described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote:"double blind" but not specifically described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None described. |
Selective reporting (reporting bias) | Unclear risk | We did not assess the trial protocol. |
Other bias | Unclear risk | No baseline differences. |