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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Wilkinson 1989.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 95

  • Age (mean ± SD, median (IQR), median (range)): NA

  • Weight (mean ± SD, median (IQR), median (range)): NA

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): NA

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 23.16/18.95

  • Type of general anaesthesia: inhalational anaesthesia (halothane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA

  • Use of perioperative opioids (if yes, which?): no significant difference in opioid analgesic usage between the 2 groups

  • Type of surgery: plastic surgical or orthopaedic procedure


Hyoscine
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 95

  • Age (mean ± SD, median (IQR), median (range)): NA

  • Weight (mean ± SD, median (IQR), median (range)): NA

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): NA

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 25.26/34.74

  • Type of general anaesthesia: inhalational anaesthesia (halothane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): NA

  • Use of perioperative opioids (if yes, which?): no significant difference in opioid analgesic usage between the 2 groups

  • Type of surgery: plastic surgical or orthopaedic procedure


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
Interventions Intervention characteristics
Placebo
  • Dose: placebo patch

  • Time point of administration: 7 to 12 hours before undergoing minor orthopaedic or plastic surgery

  • Route of administration: transdermal

  • Rescue antiemetics (if yes, which?): metoclopramide, prochlorperazine


Hyoscine
  • Dose: NA

  • Time point of administration: 7 to 12 hours before undergoing minor orthopaedic or plastic surgery

  • Route of administration: transdermal

  • Rescue antiemetics (if yes, which?): metoclopramide, prochlorperazine

Outcomes Vomiting (0 to 24 hours)
  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)
  • Outcome type: general notes on side effects

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
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