Waldmann 1985.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
|
Participants |
Baseline characteristics Placebo
Domperidone
Metoclopramide
Included criteria: un‐premedicated women requiring day‐care terminations Excluded criteria: NA Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |
|
Interventions |
Intervention characteristics Placebo
Domperidone
Metoclopramide
|
|
Outcomes |
PONV (0 to 24 hours)
|
|
Identification |
Sponsorship source: NA Country: UK Setting: outpatient, single‐centre Author's name: C.S. Waldmann Institution: Anaesthetics Unit, London Hospital Medical College, Whitechapel, London, UK Email: NA Address: Anaesthetics Unit, London Hospital Medical College, Whitechapel, London El 1BB, UK Duration of study: NA Language: English Study's primary outcome: NA Trial registry number: NA |
|
Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "a randomised double‐blind investigation was undertaken to assess the value of domperidone and metoclopramide as prophylactic anti‐emetics in unpremedicated patients undergoing general anaesthesia for therapeutic abortion on a day care basis" Quote: "sixty randomly numbered ampoules" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Quote: "sixty randomly numbered ampoules containing 2 ml normal saline, 2 ml (10 mg) metoclopramide, or 2 ml (10 mg) domperidone were disguised in the pharmacy and issued as the 'anti‐emetic' solution" Judgement comment: no statement on identical appearance of the ampoules provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "a randomised double‐blind investigation was undertaken to assess the value of domperidone and metoclopramide as prophylactic anti‐emetics in unpremedicated patients undergoing general anaesthesia for therapeutic abortion on a day care basis" Judgement comment: insufficient information on blinding ("double‐blind") |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "the incidence of nausea and vomiting in the recovery room was assessed by the recovery staff. On full recovery the patients received a questionnaire to take home, complete and return the following day" Judgement comment: insufficient information on blinding ("double‐blind") |
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 | Unclear risk | Quote: "patients in each of the three drug groups had similar weight, age, length of pregnancy and duration of anaesthetic" Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |