Schultz 2003.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Droperidol
Placebo
Included criteria: over 18 years of age, able to read and write English, low risk of anaesthesia issues, scheduled for inpatient surgery after gynaecological surgery Excluded criteria: pregnancy, surgery for cancer within previous 5 years, chemotherapy or radiation therapy within 5 years, antiemetic within 24 hours before surgery, previous use of acupressure bands, peripheral neuropathy Pretreatment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear; (duration of anaesthesia): yes |
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Interventions |
Intervention characteristics Droperidol
Placebo
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Outcomes |
Nausea (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: Seabands UK Ltd contributed the Seabands for the study Country: USA Setting: inpatient, single‐centre Author's name: Alyce A. Schultz Institution: New England Rehabilitation Hospital of Portland Email: Schula@mmc.org Address: Alyce A. Schultz, RN, PhD, Nurse Researcher, Maine Medical Center, 22 Bramhall Street, Portland, ME 04102, USA Duration of study: July 1999 to August 2000 Language: English Study's primary outcome: nausea Trial registry number: NA |
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Notes | Two out of 4 groups relevant (acupressure bands) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Judgement comment: quote: "random table number" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: quote: "study envelopes ... were prepared by the principal investigator and the study pharmacist..." Not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE). Unclear who performed randomization |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Judgement comment: quote: "the envelope containing the study group designation was opened by the admitting nurse and placed on the front of the subject's chart" "An anesthesiologist gave the study drug". Study personnel probably was not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no statement on blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | High risk | Judgement comment: quote: "one hundred and forty‐three women consented the study. One hundred and three women completed the hospital phase of the study...the most frequent reason for attrition was non‐administration of the study drug". High rate of missing outcome data (> 15%) |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | High risk | Judgement comment: baseline characteristics (age): no; (weight, BMI, ASA): unclear. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear; (duration of anaesthesia): yes |