NCT00888329.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Aprepitant
Placebo
Included criteria: scheduled for elective hysterectomy at Mayo Clinic in Arizona; ASA I, II, or III Excluded criteria: pregnancy; concomitant bowel surgery other than appendectomy; hypersensitivity to study drug or rescue medication; preoperative score for nausea > 4 out of 10 points; severe hepatic insufficiency (Child‐Pugh score > 9); any condition that impairs the patient's ability to complete study assessments; intraoperative haemodynamic instability; ICU admission; prolonged postoperative intubation; rifampin, carbamazepine, phenytoin, or other drugs that strongly induce CYP3A4 activity; other antiemetic within 12 hours before surgery; participation in a clinical trial using an investigational product Pretreatment: baseline characteristics (age): no; (weight, ASA): unclear. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids, duration of surgery): unclear |
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Interventions |
Intervention characteristics Aprepitant
Placebo
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Outcomes |
Vomiting (0 to 24 hours)
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Identification |
Sponsorship source: Mayo Clinic Country: USA Setting: inpatient/outpatient, single‐centre Author's name: Javier Magrina Institution: Mayo Clinic, Phoenix, Arizona, United States, 85054, USA Email: magrina.javier@mayo.edu Address: Mayo Clinic, Phoenix, Arizona, United States, 85054, USA Duration of study: July 2007 to October 2011 Language: English Study's primary outcome: number of patients with emesis within 24 hours Trial registry number: NCT00888329 |
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Notes | Results posted only on ClinicalTials.gov (study terminated due to slow accrual) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "results might have been influenced by selection bias“ (comment in limitations and caveats) |
Allocation concealment (selection bias) | High risk | Quote "results might have been influenced by selection bias“ (comment in limitations and caveats) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote “masking: quadruple (participant, care provider, investigator, outcome assessor)” Judgement comment: no other statements |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote “masking: quadruple (participant, care provider, investigator, outcome assessor)” Judgement comment: no other statements |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote “primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group” Judgement comment: substantial amount of missing data; no reason given |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: NCT00888329 (retrospective registration) |
Other bias | Unclear risk | Judgement comment: baseline characteristics (age): no; (weight, ASA): unclear. Potential effect modifiers (gender): no; (history of ponv/motion sickness, non‐smoker, perioperative opioids, duration of surgery): unclear |