Rodrigo 1994.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Ondansetron
Placebo
Included criteria: 18 to 48 years of age, ASA I or II, scheduled to undergo minor oral surgery (removal of impacted third molar teeth) that could not be carried out under local anaesthesia Excluded criteria: males weighing more than 120 kg, females weighing more than 100 kg, pregnant, breastfeeding, allergic to ondansetron Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |
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Interventions |
Intervention characteristics Ondansetron
Placebo
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Outcomes |
Vomiting (0 to 24 hours)
PONV (0 to 24 hours)
Headache (0 to 24 hours)
Constipation (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: Glaxo (Hong Kong Ltd) supplied ondansetron Country: Hong Kong Setting: inpatient, single‐centre Author's name: M.R.C. Rodrigo Institution: Department of Maxillofacial Surgery, Dental Faculty, University of Hong Kong Email: NA Address: Block 1, Flat A8, 23 Sha Wan Drive, Pokfulam, Hong Kong Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: 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: "random allocation chart" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind study" Judgement comment: quote: "the test drug was drawn up by the nursing officer of the operating theatre and was given by the anaesthetist, thus making it blind to patients, the anaesthetist and the surgeons" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no statement on blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: quote: "eighty patients were included in the study. Of these results, three patients were eliminated as instead of paracetamol two had been given oral difluisal and one Panadeine..." Reasons for exclusion described and unrelated to the 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, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |