Tropisetron versus metoclopramide for nausea and vomiting in the emergency department: a randomised, double blinded, clinical trial
Phase 3
Completed
- Conditions
- nausea and vomitingOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12609000733279
- Lead Sponsor
- Austin Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients who have presented to the emergency department for treatment; age 18 years or more; nausea and/or vomiting that requires drug treatment as determined by the treating physician
Exclusion Criteria
Refusal to participate; Migraine (metoclopramide sedation confers an advantage); Inability to co-operate or consent due to debility, significant illness, language barriers, altered consciousness (as determined by the emergency department or study staff); Known allergy or hypersensitivity to tropisetron or metoclopramide; Intoxication (alcohol, substance abuse); Pregnancy; Previous administration of antiemetic within 24 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ausea score (0-100) on a visual analogue scale[0, 30, 60, 90, 120, 180 and 240 minutes after drug injection];Incidence of vomiting[0, 30, 60, 90, 120, 180 and 240 minutes after drug injection]
- Secondary Outcome Measures
Name Time Method requirement for rescue medication (additional drugs to control nausea and/or vomiting) as determined by the treating medical staff (not by nausea score)[0, 30, 60, 90, 120, 180 and 240 minutes after drug injection];Side effects including drowsiness (measured using a 5 point sedation scale), dystonic reactions (determined clinically by the treating the clinicians) and akathisia (measured using the Prince Henry Hospital Akathisia Rating Scale.[0, 30, 60, 90, 120, 180 and 240 minutes after drug injection]