Warusevitane 2015.
Methods | Randomisation via a random numbers list generated by an independent statistician Double‐blind Analysis by ITT unclear |
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Participants | 1 centre in UK 60 participants within 7 days of acute ischaemic or haemorrhagic stroke confirmed by CT scan of the brain who required nasogastric feeds for > 24 hours Mean age: 78 No significant differences between baseline characteristics |
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Interventions | Rx: 10 mg metoclopramide (10 mL) C: 10 mL normal saline Treatment duration: 21 days or until NGT no longer needed |
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Outcomes | Swallowing impairment using dysphagia outcome and severity scale | |
Notes | Exclusions: signs and symptoms of pneumonia after stroke onset, history of chronic neurodegenerative disease that could affect swallowing (e.g. Parkinson disease, motor neuron disease), oesophageal disorders, contraindications to metoclopramide. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by numbers list generated by an independent statistician |
Allocation concealment (selection bias) | Low risk | Allocation sequence concealed from participants |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind trial |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind trial |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Researcher and medical team involved in participants' care blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All 60 participants analysed at end of trials (none excluded) |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None identified |