Wilkinson 1989.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Placebo
Hyoscine
Included criteria: ASA I or II, elective plastic surgical or orthopaedic procedure of less than 2 hours' duration, 16 to 65 years of age, weighing between 40 and 100 kilograms, no history of gastro‐oesophageal reflux or regular antiemetic or anticholinergic medication Excluded criteria: NA Pretreatment: baseline characteristics (ASA): no; (age, weight): unclear. Potential effect modifiers (history of PONV): no; (gender, duration of anaesthesia, non‐smoker, perioperative opioids): unclear; (history of motion sickness): yes |
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Interventions |
Intervention characteristics Placebo
Hyoscine
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Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: a grant from Ciba‐Geigy (New Zealand) Ltd. Country: New Zealand Setting: inpatient and outpatient, single‐centre Author's name: F.M. Davis Institution: Departments of Anaesthesia and Commmunity Health, Christchurch School of Medicine, Christchurch, New Zealand Email: NA Address: Depanment of Anaesthesia, Christchurch School of Medicine, P.O. Box 4345, Christchurch, New Zealand Duration of study: NA Language: English Study's primary outcome: incidence of vomiting Trial registry number: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "supplied by Ciba‐Geigy (NZ) Ltd. Random number lists were used to assign patients to one of two treatment groups, and a sealed enveloped containing..." |
Allocation concealment (selection bias) | Unclear risk | Quote: "a sealed enveloped containing the trial medication, either Scopoderm or a placebo patch, was allocated for each patient" Judgement comment: not stated; sequentially numbered, opaque, and sealed envelope (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "identical, unlabelled patches containing either hyoscine or placebo were supplied by Ciba‐Geigy (NZ) Ltd. Random number lists were used" Quote: "using a double‐blind technique" Judgement comment: insufficient information on who was blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "patients were carefully interviewed either personally or by telephone by a trained independent observer" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "of the 221 patients entering the trial, 31 were subsequently excluded for the reasons outlined in Table 1" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | High risk | Quote: "there were no demographic differences between the two treatment groups, each of 95 subjects, excepting that the hyoscine group contained more individuals with a past history of motion sickness (P < 0.05)" Judgement comment: baseline characteristics (ASA): no; (age, weight): unclear. Potential effect modifiers (history of PONV): no; (gender, duration of anaesthesia, non‐smoker, perioperative opioids): unclear; (history of motion sickness): yes |