Skip to main content
. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Waldmann 1985.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 24.6 ± 6.61

  • Weight (mean ± SD, median (IQR), median (range)): 58.5 ± 7.93

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 12.1

  • Use of perioperative opioids (if yes, which?): 0.05 mg fentanyl, pethidine

  • Type of surgery: day‐care termination


Domperidone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 21.7 ± 4.4

  • Weight (mean ± SD, median (IQR), median (range)): 56.6 ± 8.73

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 16

  • Use of perioperative opioids (if yes, which?): 0.05 mg fentanyl, pethidine

  • Type of surgery: day‐care termination


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 23.2 ± 5.96

  • Weight (mean ± SD, median (IQR), median (range)): 60 ± 6.93

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 14.2

  • Use of perioperative opioids (if yes, which?): 0.05 mg fentanyl, pethidine

  • Type of surgery: day‐care termination


Included criteria: un‐premedicated women requiring day‐care terminations
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Placebo
  • Dose: saline

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Domperidone
  • Dose: 10 mg

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Metoclopramide
  • Dose: 10 mg

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA

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

Identification Sponsorship source: NA
Country: UK
Setting: outpatient, single‐centre
Author's name: C.S. Waldmann
Institution: Anaesthetics Unit, London Hospital Medical College, Whitechapel, London, UK
Email: NA
Address: Anaesthetics Unit, London Hospital Medical College, Whitechapel, London El 1BB, UK
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "a randomised double‐blind investigation was undertaken to assess the value of domperidone and metoclopramide as prophylactic anti‐emetics in unpremedicated patients undergoing general anaesthesia for therapeutic abortion on a day care basis"
Quote: "sixty randomly numbered ampoules"
Judgement comment: no further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Quote: "sixty randomly numbered ampoules containing 2 ml normal saline, 2 ml (10 mg) metoclopramide, or 2 ml (10 mg) domperidone were disguised in the pharmacy and issued as the 'anti‐emetic' solution"
Judgement comment: no statement on identical appearance of the ampoules provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "a randomised double‐blind investigation was undertaken to assess the value of domperidone and metoclopramide as prophylactic anti‐emetics in unpremedicated patients undergoing general anaesthesia for therapeutic abortion on a day care basis"
Judgement comment: insufficient information on blinding ("double‐blind")
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "the incidence of nausea and vomiting in the recovery room was assessed by the recovery staff. On full recovery the patients received a questionnaire to take home, complete and return the following day"
Judgement comment: insufficient information on blinding ("double‐blind")
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "patients in each of the three drug groups had similar weight, age, length of pregnancy and duration of anaesthetic"
Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear