Patka 2011.
| Methods | Study design: prospective, randomized, active controlled, double‐blinded study Study duration: not stated Follow‐up: 120 min |
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| Participants | Country: not stated Setting: not stated Annual census: not stated Inclusion criteria: if admitted to ED with nausea or vomiting, or both Exclusion criteria: previous treatment in the ED with antiemetics; missed last menstrual period or pregnancy; aged < 18 years; conditions with impaired gastrointestinal tract function (i.e. irritable bowel syndrome); impaired mental status; treatment with antineoplastic agents within 7 days prior to randomization; people unable to read English language; people leaving the ED against medical advice Number: total 64; treatment group 1 (32); treatment group 2 (32) Mean age (years) (SD not reported): treatment group 1 (41); treatment group 2 (40) Sex (M/W): treatment group 1 (15/17); treatment group 2 (14/18) |
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| Interventions | Treatment group 1: prochlorperazine 10 mg IV Treatment group 2: ondansetron 4 mg IV Prochlorperazine administered as single pushed dose over 2 min and ondansetron administered pushed over 2‐5 min |
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| Outcomes | Primary outcome: number of vomiting episodes. Secondary outcomes: change in nausea severity score at 30 (60 and 120 min), proportion of participants requiring rescue medication, adverse effects (sedation, headache, akathisia) |
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| Notes | Additional data provided by author ‐ means and SD for treatment groups, and clarifications about methodology | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were assigned to treatment using a 1 : 1 random numbers table |
| Allocation concealment (selection bias) | Unclear risk | Mechanism for allocation concealment not elucidated in report |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Mechanism for blinding not reported. Inconsistency with "blinding" in reporting, e.g. reported as double blind, however reported interventions differed in their administration times 2 vs. 2‐5 min |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcomes were self reported; however' mechanism for blinding not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data for some outcomes, but unlikely to have substantial effect on results |
| Selective reporting (reporting bias) | Low risk | Primary outcome of review reported satisfactorily. Secondary outcomes incompletely reported, e.g. VAS scores for headache and sedation reported divided into quartiles only. Unlikely to substantially influence results |
| Other bias | Unclear risk | Generally poor reporting, no reasons given for non‐recruitment substantial numbers screened |
CCF: congestive cardiac failure; ED: emergency department; IQR: interquartile range; IV: intravenous; M: men; min: minute; SD: standard deviation; VAS: visual analogue scale; W: women.