Bang 2016.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Placebo
Palonosetron
Included criteria: women 20 to 60 years of age with American Society of Anesthesiologists physical status I or II Excluded criteria: patients who experienced vomiting or retching in the 24‐hour period before surgery; patients who underwent emetogenic radiotherapy within 8 weeks or cancer chemotherapy within 4 weeks before study entry; patients who had received steroids, antiemetics, or psychoactive medications 24 hours before study initiation Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |
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Interventions |
Intervention characteristics Placebo
Palonosetron
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 2 hours)
Vomiting (2 to 6 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Subjects with any SAE (0 to 24 hours)
Headache (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: there are no financial or other relationships to disclose that might lead to a conflict of interest regarding this article Country: Korea Setting: inpatient, single‐centre Author's name: Soo Kyoung Park Institution: Department of Anesthesiology and Pain Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Gyeonggi, Korea Email: hardmong@naver.com Address: Department of Anesthesiology and Pain Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keun Jaebong Road, Hwaseong, Gyeonggi, Korea Duration of study: June to October 2015 Language: English Study's primary outcome: the primary outcome was the overall incidence of nausea and vomiting during the first 24 hours after anaesthesia Trial registry number: NCT01478165 |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "using a computer‐generated number table" |
Allocation concealment (selection bias) | Unclear risk | Quote: "trained nurses, who were not involved in the study, prepared the study drugs before induction of anesthesia, according to directions in an envelope containing the allocation groups" Judgement comment: not stated sequentially numbered, opaque, and sealed envelopes (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "trained nurses, who were not involved in the study, prepared the study drugs before induction of anesthesia, according to directions in an envelope containing the allocation groups" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "every assessment and interview was performed by doctors blinded to treatment group enrolment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "one hundred patients were enrolled (50 per group) and all completed the study" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: NCT01478165 (retrospective registration) |
Other bias | Low risk | Quote: "patient demographic data, risk factors and operative data were comparable between the two groups (Table 1)" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |