Egerton‐Warburton 2014.
| Methods | Study design: double‐blind, randomized controlled trial Study duration: September 2009 to April 2010 Follow‐up: 30 min |
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| Participants | Country: Australia Setting: 2 EDs, 1 urban district and 1 tertiary referral Annual census: 57,000 (urban district) and 59,000 (tertiary referral) Inclusion criteria: aged ≥ 18 years, and nausea or vomiting (or both) during their ED episode of care for which the attending doctor recommended IV Exclusion criteria: haemodynamic instability or primary diagnosis requiring time critical intervention; pregnancy or lactation, Parkinson's disease or restless leg syndrome; use of any antiemetic drug in the previous 8 hours or prior IV fluid in ED, ED nausea or vomiting that was motion related or associated with vertigo; currently undergoing chemotherapy or radiotherapy; inability to understand study explanation of outcome measures; known allergy or previous adverse reaction to study drugs Number: total 258; treatment group 1 (87); treatment group 2 (88); control group (83) Median age, IQR (years): treatment group 1 (42, 27‐61); treatment group 2 (42, 27‐67); control group (42, 28‐62) Sex (M/W): treatment group 1 (31/56); treatment group 2 (30/58); control group (28/55) |
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| Interventions | Treatment group 1: ondansetron 4 mg IV Treatment group 2: metoclopramide 10 mg IV Control group: placebo All interventions were administered as a single push over 2 min All groups received IV fluid over the 30‐min study period |
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| Outcomes | Primary outcome: change in nausea severity score at 30 min Secondary outcomes: proportion of participants requiring rescue medication, adverse reactions, participant satisfaction |
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| Notes | Median (IQR) IV fluid received: group 1 180 (125‐250); group 2 200 (125‐300); control group 200 (125‐250) Additional data provided by author ‐ means and SD for treatment groups |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random number sequence in blocks of 6 by independent trial pharmacist |
| Allocation concealment (selection bias) | Low risk | Study drug prepared and packed in sequentially numbered packs by independent pharmacist |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All 3 study drugs prepared to look identical as 2 x 2 mL syringes of clear fluid, labelled only as study medications |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Code not broken until after all data entry and analysis complete |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Incomplete data for 12/270 participants. Small likelihood of bias |
| Selective reporting (reporting bias) | Low risk | No indication of selective reporting |
| Other bias | Low risk | No other biases |