Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.
Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.
Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL