Semple 1992.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Hyoscine patch
Placebo
Included criteria: 18 to 65 years of age, ASA I or II, requiring general anaesthesia for abdominal hysterectomy Excluded criteria: NA 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 Hyoscine patch
Placebo
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Outcomes |
Vomiting (0 to 2 hours)
Vomiting (day 1 after PACU)
Visual disturbances (e.g. blurred vision) (first postoperative day, day 2, day 3)
Adverse events (general notes in the publication, 3 days' observation)
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Identification |
Sponsorship source: NA Country: UK Setting: inpatient, single‐centre Author's name: P. Semple Institution: York District Hospital Email: NA Address: Department of Anaesthesia, York District Hospital, Wigginton Road, York YO3 7HE, UK Duration of study: NA Language: English Study's primary outcome: NA 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 | Judgement comment: quote: "randomly allocated". No further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the placebo was a standard waterproof dressing (Johnson and Johnson) and each hyoscine patch was covered by a similar dressing, so that its identity could not be distinguished from placebo by patient or assessor. The patches were applied by a nurse who was not involved with subsequent assessment" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the placebo was a standard waterproof dressing (Johnson and Johnson) and each hyoscine patch was covered by a similar dressing, so that its identity could not be distinguished from placebo by patient or assessor. The patches were applied by a nurse who was not involved with subsequent assessment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "seventy‐two patients were recruited into the trial but five were later withdrawn: two patients had problems with the PCA (one severe itching, one was unable to operate it) and both were converted to intramuscular analgesia, one patient was inadequately followed up, one patch was accidentally removed and one patient developed an allergy to the dressing. Of the remaining 67 subjects, 37 were in the active group and 30 in the placebo group" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to 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 |