Cholwill 1999.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
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Participants |
Baseline Characteristics Ondansetron
Cyclizine
Placebo
Included criteria: ASA I or II, women undergoing day‐case gynaecological laparoscopy Excluded criteria: antiemetic drugs, pregnant or breastfeeding, body mass index (BMI) > 30 kg/m² Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, (history of PONV/motion sickness, perioperative opioids): no; duration of anaesthesia, non‐smoker): unclear |
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Interventions |
Intervention characteristics Ondansetron
Cyclizine
Placebo
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Outcomes |
Vomiting (0 to 6 hours)
Sedation/drowsiness (0 to 6 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: UK Setting: outpatient, single‐centre Author's name: J.M. Cholwill Institution: Department of Anaesthesia, Nottingham City Hospital, Nottingham, UK Email: NA Address: Department of Anaesthesia, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK Duration of study: NA Language: English Study's primary outcome: primary outcome measures were incidence of moderate or severe nausea or vomiting and number of patients receiving escape antiemetic Trial registry number: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were allocated randomly, with stratification for past history of PONV" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the drugs were blinded to patients, investigators and recovery room staff" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the drugs were blinded to patients, investigators and recovery room staff" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: 5 patients were withdrawn (1 required a mini‐laparotomy, and data collection was incomplete in 4). All outcomes of the remaining 175 participants were analysed before discharge. Thirteen patients were admitted after surgery: 7 with PONV (2 from the ondansetron group and 4 from the saline group) and 6 for surgical reasons. Data from these patients and from the 53 patients who received rescue antiemetics were excluded from further analysis (after discharge) |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "patient data were comparable in all groups (Table 1)" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, (history of PONV/motion sickness, perioperative opioids): no; duration of anaesthesia, non‐smoker): unclear |