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.
Age range
18 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
Timeframe: Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.
To identify and characterize the clinical determinants of hospitalized patients receiving tropicamide/phenylephrine 8 mg/50 mg/mL at the Instituto de Oftalmología Conde de Valenciana
Timeframe: At enrollement
To actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL.
Timeframe: At enrollment Measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours afterward.