Jokela 2002.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
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Participants |
Baseline Characteristics Ondansetron
Tropisetron
Metoclopramide
Included criteria: adult, ASA I to III, female, scheduled for thyroid or parathyroid surgery Excluded criteria: NA Pretreatment: baseline characteristics (age, BMI, 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 Ondansetron
Tropisetron
Metoclopramide
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Outcomes |
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Headache (0 to 24 hours)
Visual disturbances (e.g. blurred vision) (0 to 24 hours)
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Identification |
Sponsorship source: NA Country: Finland Setting: inpatient, multi‐centre (3) Author's name: Ritva Jokela Institution: Department of Anaesthesia and Intensive Care, Helsinki University Email: ritva.m.jokela@hus.fi Address: Department of Anaesthesia and Intensive Care, Helsinki University, PB 140 (Haartmaninkatu 2), FIN‐00029 HUCH, Finland Duration of study: NA Language: English Study's primary outcome: PONV 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: "the patients were randomly assigned (sealed envelope technique)" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: stated: "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: no statement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "a study nurse or one of the investigators interviewed the patients after 2 hours in the PACU and after 24 hours on the ward" Judgement comment: no statement on blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "we enrolled 200 patients in the study. Six patients were excluded as a result of a reoperation during the study period and 15 patients because of protocol violations. In the final analysis we had 179 patients: 60 in the ondansetron (Group O) and tropisetron (Group T) groups, and 59 in the metoclopramide (Group M) group. One hundred and sixteen patients were studied at Oulu University Hospital, 37 at Lapland Central Hospital, and 26 at Kuopio University Hospital" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Low risk | Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |