Judkins 1982.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis, dose‐finding study |
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Participants |
Baseline characteristics Haloperidol (10 mg group)
Haloperidol (5 mg group)
Placebo
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 |
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Interventions |
Intervention characteristics Haloperidol (10 mg group)
Haloperidol (5 mg group)
Placebo
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Outcomes |
Adverse events (general notes in the publication, 24 hours' observation)
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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 |
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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: "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 |