Gan 2004.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Ondansetron
Placebo
Included criteria: undergoing major breast surgery Excluded criteria: pregnant, experiencing menstrual symptoms, using a permanent cardiac pacemaker, had previous experience with acupuncture therapies, had received any antiemetic medication or had experienced nausea, vomiting, or retching within 24 hours of surgery Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
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Interventions |
Intervention characteristics Ondansetron
Placebo
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Outcomes |
Vomiting (0 to 2 hours)
Vomiting (2 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: USA Setting: outpatient, single‐centre Author's name: Tong J. Gan Institution: Departments of Anesthesiology and Plastic Surgery, Duke University Medical Center, Durham, North Carolina, USA Email: gan00001@mc.duke.edu Address: Department of Anesthesiology, Duke University Medical Center, Box 3094, Durham, NC 2771, USA Duration of study: NA Language: English Study's primary outcome: incidence of nausea Trial registry number: NA |
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Notes | Two out of 3 groups relevant (electro‐acupoint stimulation) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was achieved using a random number generator" |
Allocation concealment (selection bias) | Unclear risk | Quote: "in a sealed envelope technique..." Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the anesthesiologists and care providers were blinded to the study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "postoperative data were collected by a separate research nurse not involved in the preoperative or intraoperative management of patients" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "seventy‐seven patients were enrolled in the study. One patient from the O group did not have her scheduled surgery and one patient from the P group withdrew from participation before the administration of study procedure. Seventy‐five patients completed the study" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "there was no difference in patient demographics among the groups..." Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |