The crossover clinical trial to evaluate the effect of oral propranolol or back skin hemangioma in children less than 15 years admitted to hospital with Amir Kabir performed. Inclusion criteria: age under 15 years, numerous Hemangiomas, tumor size greater than 5 cm, as between hemangioma. Exclusion criteria: age over 15 years, underlying heart disease, asthma, liver or kidney dysfunction, hypoglycemia, or low blood pressure as a result of drug use. The sample size is 32 students. Two groups of 16 patients aged 5 years and 5 years and above are divided. One group was treated with propranolol in the 2mg/kg for six months and is considered a group. If the pressure of the injury and damage caused to a large extent be excluded and replaced the indications for treatment. After six months, a period of one week to the elimination half-life of propranolol is given and the groups are reversed. Being continuously monitored by measuring the lesion occurs monthly during treatment, patients three days a week and once a month after the start of treatment and the evaluation of the size and color of your blood sugar levels are and after six months of treatment during the last two weeks of therapy, the medication is discontinued and the patient gradually until six months after the treatment in terms of recurrence of cardiovascular risk factors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011920715N1
Registration date:2015-05-04, 1394/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-04, 1394/02/14
Registrant information
Name
Aziz Eghbali
Name of organization / entity
دانشگاه علوم پزشکی اراک
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.eghbali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-10-02, 1393/07/10
Expected recruitment end date
2015-10-02, 1394/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral propranolol on coetaneous hemangioma in children under 15 years of Amir Kabir Hospital
Public title
Effect of oral propranolol on benign vascular tumors in children under 15 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age under 15 years; numerous Hemangiomas; tumor size greater than 5 cm; Hemangioma on the face and nose. Exclusion criteria: age over 15 years; underlying heart disease; asthma; liver or kidney dysfunction; hypoglycemia; or low blood pressure due to drug use; consent to continue the study; the presence of compression lesion during the period under consideration.
Age
From 78 years old to 93 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak university of medical science
Street address
Arak, Hoda Science, University of Medical Sciences