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

Judkins 1982.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis, dose‐finding study
Participants Baseline characteristics
Haloperidol (10 mg group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 12

  • Age (mean ± SD, median (IQR), median (range)): 47.5

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): NA

  • Non‐smoker (%): NA

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

  • 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?): fentanyl (up to 0.2 mg), pethidine via Cardiff Palliator: 529.8 mg (180 to 1080)

  • Type of surgery: cholecystectomy, biliary bypass surgery, surgery for duodenal ulcer


Haloperidol (5 mg group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 11

  • Age (mean ± SD, median (IQR), median (range)): 57.0

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): NA

  • Non‐smoker (%): NA

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

  • 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?): fentanyl (up to 0.2 mg), pethidine via Cardiff Palliator: 602.7 mg (300 to 1140)

  • Type of surgery: cholecystectomy, biliary bypass surgery, surgery for duodenal ulcer


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 11

  • Age (mean ± SD, median (IQR), median (range)): 47.0

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

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): NA

  • Non‐smoker (%): NA

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

  • 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?): fentanyl (up to 0.2 mg), pethidine via Cardiff Palliator: 478.3 mg (210 to 1410)

  • Type of surgery: cholecystectomy, biliary bypass surgery, surgery for duodenal ulcer


Included criteria: between 18 and 70 years of age, scheduled for elective major upper abdominal surgery but otherwise fit
Excluded criteria: NA
Pretreatment: baseline characteristics (ASA, weight): unclear; (age): yes. Potential effect modifiers (perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear; (gender): yes
Interventions Intervention characteristics
Haloperidol (10 mg group)
  • Dose: 10 mg

  • Time point of administration: as premedication

  • Route of administration: NA

  • Rescue antiemetics (if yes, which?): 17% NA


Haloperidol (5 mg group)
  • Dose: 5 mg

  • Time point of administration: as premedication

  • Route of administration: NA

  • Rescue antiemetics (if yes, which?): 18% NA


Placebo
  • Dose: NA

  • Time point of administration: as premedication

  • Route of administration: NA

  • Rescue antiemetics (if yes, which?): 73% NA

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

Identification Sponsorship source: the study authors would like to thank G.D. Searle and Co., for supplies of haloperidol and placebo and for financial and technical support
Country: UK
Setting: NA
Author's name: K.C. Judkins
Institution: Royal Gwent Hospital, Newport. Gwent NPT 2UB
Email: NA
Address: NA
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement comment: quote: "randomised". 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 Unclear risk Judgement comment: insufficient information on blinding ("double‐blind study")
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blind study")
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 High risk Quote: "...and surgery for duodenal ulcer. More females were recruited to the placebo and to the 10 mg haloperidol study groups than to the 5 mg haloperidol group. This latter group tended to be older with a median age of 57.0 years as compared with 47.0 and 47.5 years respectively for the placebo. Weights ranged from 47.5 to 87.0 kg. Dosage of pethidine (mean and range) taken by patients is given in Table 1 and graphically presented in Fig. 1. It can be seen firstly that there was wide individual variation in dosage required; secondly that the dose of analgesic needed was greatest in the first 6 postoperative hours and thereafter fell dramatically; and finally that differences in analgesic requirements between treatment groups were not statistically significant"
Judgement comment: baseline characteristics (ASA, weight): unclear; (age): yes. Potential effect modifiers (perioperative opioids): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker): unclear; (gender): yes