A study to compare the effect of two drugs, oral hydroxyzine and oral triclofos for sedation of children undergoing echocardiography.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Hydroxyzine: Oral hydroxyzine syrup(10mg/5ml) administered at a dose of 1mg/kg 30 minutes before transthoracic echocardiography. Control Intervention1: Triclofos: Oral triclofos syrup(500mg/5ml) administered at a dose of 50mg/kg 30 minutes before transthoracic echocardiography. CONDITION: Health Condition 1: B‐ Imaging PRIMARY OUTCOME: Proportion of children with successful echocardiography completion, RSS 4 or more plus complete the procedure without significant interruption.Timepoint: Till completion of procedure SECONDARY OUTCOME: Duration of adequate sedation.Timepoint: From achieving modified RSS 4 or more until eye opening. Need for rescue doses for sedationTimepoint: During transthoracic echocardiography procedure Proportion of children with adverse effects.Timepoint: During sedation and until discharge Time taken for adequate sedationTimepoint: From administration of the sedative to achieving Modified RSS 4 or more Time taken to recovery after the procedure.Timepoint: From eye opening until discharge. INCLUSION CRITERIA: All children aged 2 months to 5 years undergoing transthoracic echocardiography who require sedation for adequate image acquisition and successful completion of the procedure.
Epistemonikos ID: 30b3d35f6973acd5311e03e296f0f38882bda28a
First added on: Oct 08, 2026