Condition: Adverse Drug Effect · Phenylephrine · Hypertension · Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL. An ambispective, interventional, longitudinal study will be conducted to actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL, as well as the clinical determinants that may predispose patients to the occurrence of an adverse drug reaction (ADR). Data will be collected through the administration of a questionnaire and measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and subsequently at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours after administration, with the aim of establishing an association between these variables.
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| Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro | Mexico City, Mexico Ciy, Mexico | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07178600