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. 2021 May 18;2021(5):CD007579. doi: 10.1002/14651858.CD007579.pub3

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)
  • Nalbuphine 4 mg.

  • N = 60.


Intervention 2: 5‐HT3antagonist (Comparson 1)
  • Ondansetron 4 mg.

  • N = 60.


Intervention 3: 5‐HT3antagonist (Comparson 1)
  • Ondansetron 8 mg.

  • N = 60.


Comparator: placebo.
  • Normal saline.

  • N = 60.

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)
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.