Paech 2003.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
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Participants |
Baseline characteristics Tropisetron
Ondansetron
Dolasetron
Included criteria: scheduled for major open abdominal gynaecological or gynaecological oncological procedure Excluded criteria: experiencing preoperative nausea, receiving medication with antiemetic activity or with contraindications to non‐steroidal anti‐inflammatory medication or epidural anaesthesia, women in whom an open procedure was not performed or who underwent unplanned bowel surgery Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
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Interventions |
Intervention characteristics Tropisetron
Ondansetron
Dolasetron
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (recovery room)
Vomiting (18 to 24 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: a small proportion of each study drug was supplied free by the respective pharmaceutical companies (Novartis for tropisetron, GlaxoWellcome for ondansetron, Hoechst Marion Roussel for dolasetron) Country: Australia Setting: inpatient, single‐centre Author's name: M. J. Peach Institution: Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospitalfor Women and Women and Infants Research Foundation, Perth, Western Australia Email: NA Address: King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, W.A. 6008 Duration of study: NA Language: English Study's primary outcome: incidence of vomiting Trial registry number: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Judgement comment: quote: "using a computer‐derived randomisation sequence" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: quote: "in blinded envelopes" Not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: quote: "the study drugs, known only to the attending anaesthetist who took no part in the collection of subsequent data" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: quote: "the study drug, known only to the attending anaesthetist who took no part in the collection of subsequent data" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: quote: "a total of 120 patients were recruited into the study. Excluded from analysis were two patients from group O, one of whom did not have the procedure and one who was transferred to an intensive care unit postoperatively, precluding data collection" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |