Grimsehl 2002.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Cyclizine
Ondansetron
Included criteria: ASA I and II, written informed consent, scheduled to undergo diagnostic laparoscopy or laparoscopic sterilization Excluded criteria: NA Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear |
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Interventions |
Intervention characteristics Cyclizine
Ondansetron
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to time to discharge)
Vomiting (discharge to 24 hours)
Nausea (0 to 24 hours)
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Identification |
Sponsorship source: NA Country: UK Setting: outpatient, single‐centre Author's name: K. Grimsehl Institution: Ninewells Hospital, Dundee DD1 9SY, UK Email: NA Address: Ninewells Hospital, Dundee DD1 9SY, UK Duration of study: NA Language: English Study's primary outcome: incidence of nausea 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: "randomly assigned by closed envelope technique" Judgement comment: insufficient information on random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: insufficient information on blinding ("double‐blind") |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "...mg diclofenac suppository was inserted. All assessments were carried out by a blinded investigator, who was unaware of the anti‐emetic given. Anaesthetic time was recorded as..." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "(Research Solutions Ltd, UK). Seventy‐four patients were recruited to the study and peri‐operative data were obtained for all subjects. Both groups were comparable for..." Judgement comment: at 24‐hour follow‐up: 12 patients were omitted (did not return questionnaire, required escape antiemetic, inadequate analgesia) |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "...obtained for all subjects. Both groups were comparable for patient characteristics, menstrual cycle, previous PONV and type of operation (Table 1). Anaesthetic times were similar in both groups, but mean (SD) time to..." Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear |