Chen 1996.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Metoclopramide
Ondansetron
Included criteria: ASA I or II, 18 to 60 years of age, scheduled for abdominal hysterectomy or ovarian surgery Excluded criteria: preexisting nausea or vomiting, antiemetics or opioids given in the 24 hours before surgery, pregnancy, gastro‐oesophageal reflux, alcohol or drug abuse Pretreatment: baseline characteristics (age, weight, ASA): no. 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 Metoclopramide
Ondansetron
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 4 hours)
Vomiting (12 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: NA Country: China Setting: inpatient, single‐centre Author's name: P.P. Chen Institution: Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT, Hong Kong Email: NA Address: NA Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: incidence of PONV |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: quote: "allocated randomly to receive either ondasetron 4 mg or metoclopramide 10 mg using a series of sealed envelopes" Insufficient information on the sequence generation process |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: quote: "allocated randomly to receive either ondasetron 4 mg or metoclopramide 10 mg using a series of sealed envelopes" Detailed information on envelopes is missing (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: quote: "double‐blinded" Insufficient information on blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: quote: "sedation, nausea and vomiting were assessed by an investigator blinded to the study drug" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: quote: "twenty‐five patients were initially recruited into each Group. One Patient in the metoclopramide group was excluded after she developed post‐operative respiratory depression" Reasons for missing data from 1 patient were described and are unlikely related to outcomes of interest |
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, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |