Watts 1996.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
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Participants |
Baseline characteristics Ondansetron
Metoclopramide
Cyclizine
Included criteria: women presenting for elective laparoscopic procedure on a day‐stay basis Excluded criteria: pregnant, had taken any opiate or antiemetic in the preceding 24 hours, history of hypersensitivity to any of the trial agents, on assessment were deemed to be better served by an anaesthetic different from the standard technique (obesity, reflux, difficult airway) Pretreatment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia, non‐smoker): unclear |
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Interventions |
Intervention characteristics Ondansetron
Metoclopramide
Cyclizine
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Outcomes |
PONV (0 to 24 hours)
Extrapyramidal symptoms (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: New Zealand Setting: outpatient, single‐centre Author's name: S.A. Watts Institution: Palmerston North Hospital, Palmerston North, New Zealand Email: NA Address: Department of Anaesthesia, Waikato Hospital, Hamilton, New Zealand Duration of study: NA Language: English Study's primary outcome: incidence of PONV Trial registry number: NA |
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Notes | Two studies (1 non‐randomized pilot study, 1 RCT) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the second phase was a randomized, double‐blind comparison of the efficacy of the three study antiemetics" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Quote: "all test agents were supplied to the administering anaesthetist in capped and coded syringes containing 2 ml of colourless liquid" Judgement comment: insufficient information on allocation concealment and time point of randomization |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "all test agents were supplied to the administering anaesthetist in capped and coded syringes containing 2 ml of colourless liquid" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "...hours postoperatively and at time of discharge from the day‐stay unit (usually four to six hours post operation), by the attending nursing staff. Scores at 24 hours were attained by phone or standard questionnaire via return mail by the investigator" Judgement comment: no information on blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "...166 making up the comparative trial population. Of the patients in the comparative trial, 54 were given metoclopramide (Group M), 59 received ondansetron (Group O) and 53 cyclizine (Group C)" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "...similar in the three groups for mean patient age, day of menstrual cycle and type of operation. Distribution of patients with a past history of motion sickness or previous PONV was comparable between groups and likewise there was no difference of significance in the distribution of operative procedures" Judgement comment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia, non‐smoker): unclear |