Health Condition 1: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere
Conditions
Interventions
Intervention1: Topical beta-blocker (0.5% Timolol Maleate) with Oral beta-blocker/propranolol (TOBB): The propranolol will be started at 0.25 mg for one week, followed by 0.5 mg the next week, to a m
Sponsors
AIIMS Raebareli
Eligibility
Inclusion criteria
Inclusion criteria: Mixed infantile haemangioma on Doppler including mucosal surfaces and ulcerated hemangiomas without prior treatment history
Exclusion criteria
Exclusion criteria: Multisegmented ICH Child having Persistent arrhythmias Child having wheezing Child having heart failure Child having Associated Visceral vascular lesions Patients having Raynaud phenomena Child having Bradycardia or low blood pressure according to age Child having clinioradiological evidence of Pheochromocytoma Child having Breastfeed mothers on oral propranolol or steroid or vincristine or on interferon treatment Child having Renal and liver failure with any cause of Hyperkalemia Risk of adverse effects of systematic beta blockers like Cardiac arrhythmias Primary heart block Recovered patients of cardiogenic or hypotensive shock Child having sinus bradycardia Child having Asthma Child having history of hypoglycemia Child having birth weight less than 2500 g Infant or mother taking any synergestic or antagonistic drugs like calcium channel blocker (Diltiazam Verapamil bepridil) Quinidine Amiodarone (antiarrhythmic) Digitalis Lidocaine Dihydropyridines Antihypertensives (ACE Inhibitors angiotensin II-receptors antagonists diuretics alpha-blocker Corticosteroid Nitrates derivatives Type 5-phosphodiesterase inhibitors Tricyclic antidepressants Antipsychotics Dopaminergic agonists levodopa Amifostine Baclofen Rifampicin Phenobarbital Hypoglycaemic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in each group with at least 75% improvement in the extent of the hemangioma as compared before treatment based on visual inspection for color size and thickness Timepoint: Baseline 1 day 2 days 3 days 1 week 2nd week 3rd week 4th week 2 months 3rd months 6th months 12th months | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) Adverse events during therapy in each group: Side effects of topical treatment include skin-related adverse events such as local burning, stinging, or irritant reactions. (b)Parental satisfaction on 10 point scale. Timepoint: day 0, 1 day, 2 days, 3days, 1 week (admission), and follow up at 2nd week, 3rd week, 4th week at the end of 2nd months, 3rd months, 6th months, 12th months. | — |
Countries
India
Contacts
Public ContactSunita Singh
AIIMS Raebareli
Outcome results
None listed