Role of Propranolol as Compared to Bleomycin in Management of Hemangioma
Condition: Hemangioma; Propranolol
MeSH terms: Hemangioma
Study type: Interventional

Summary: 
      Infantile hemangiomas are widespread vascular tumours having incidence of 10% and most of
      them involute spontaneously. However, they are known to be located in proximity of vital
      organs and can have poor cosmetic and functional sequel if left untreated. A wide range of
      treatment options are available from expectant therapy to radical surgical excision.
      Propanolol has also been shown to be effective in treating infantile cutaneous hemangiomas.
      Similarly, anti-metabolite drugs as bleomycin has also shown promising results. Efficacy in
      terms of reduction in size of both treatments has been scarcely studied especially in
      Pakistan.

      OBJECTIVE: To assess the efficacy of oral propranolol and intraleisonal bleomycin in the
      treatment of infantile cutaneous hemangioma in terms of size regression
    

Detailed description: 
      Material & Methods Study design: Randomised controlled trial Place of study: This is study
      was conducted in the department of paediatric surgery, children hospital, Pakistan institute
      of medical sciences, Islamabad Duration of study: 24 months

      Number of patients:

      Using the WHO sample size calculator with following statistical assumptions Confidence
      interval = 90% Alpha errors = 5% Anticipated population proportion in Group A = 85%9
      Anticipated population proportion in Group B = 62.5%9 Sample size will be 45 cases in each
      study group. Total number of 90 cases will be required in this study Sampling technique:
      Probability sampling technique Sélection criteria Inclusion criteria

      1. 6 month to 12 yr. of age presenting with infantile hemangioma anywhere on body 2. Both sex
      included 3. Previously not treated Exclusion criteria On the basis of history and clinical
      assessment;

        1. Patients with previous treatment of hemangioma.

        2. Patients who will be lost to follow up

        3. Patients who refused to be enrolled in this study

        4. Patients who experienced hypersensitivity to propranolol/Bleomycin during treatment or
           had previous known allergy to the drugs.

        5. Patients who had diagnosed Cardiac disease such as heart failure or AV block.

        6. Patients with diagnosed Pulmonary disease such as asthma or bronchiolitis.

        7. History of impaired renal or liver functions.

        8. Diabetes mellitus Collection procedure After approval of synopsis, researcher collected
           data after taking permission from hospital Ethical Committee. Patients were entertained
           through outdoor department. Patient was explained about the whole procedure. Brief
           history and clinical examination and investigations were recorded on a Performa. The
           patients who were diagnosed cases of any cardiac, pulmonary, renal or hepatic diseases
           were excluded from study based on history. Diagnosis was established on clinical grounds
           and Doppler ultrasonography of the hemangioma were done to confirm the diagnosis if
           needed. Size of hemangioma taken and any skin changes were noted.

      Patients were explained about the whole treatment and informed written consent taken.

      Number of patients: It was conducted on 90 patients that were divided in equal number to two
      groups randomly by lottery system.

      Group A: Included those who had to be managed with oral propranolol. Group B: included those
      who had to be managed with intralesional injection bleomycin.

      The patients were seen in OPD and followed up in OPD. Patients were randomly divided into two
      non biased groups. One group i.e. Group A received propranolol with a mean dose of 2mg/kg/day
      in 2 divided doses for a period of 6 months.

      Group B consisted of those who received Bleomycin 15mg diluted in 15 ml of 2% plain lidocaine
      along with a dosage of 0.5 mg/kg for a period of 6 months. The dose of lidocaine was 3mg/kg.
      It was injected intralesionaly using a syringe and a 27-gauge. Where needed, a pressure
      dressing was applied for 24 hours. A total of 6 injections were administered and the interval
      between injections was 2-4 weeks. The patients were admitted for 24 hrs in ward after General
      Anesthesia (GA) whereas, if GA was not given patient was monitored in day care. Dosage of
      bleomycin and nature of anaesthesia (i.e., general anaesthetic, local anaesthetic with or
      without sedation) were prospectively recorded for every patient and session. Vitals were
      checked in first 24hr period in both groups and noted. Those patient who exhibited any signs
      of hypersensitivity during and after administration were also left out.

      Follow up were done weekly for 1 month in both groups to see changes in size and skin in both
      groups. After that the follow up was on monthly basis till 6 months. In each visit patients
      had full clinical examination including pulse and blood pressure with recording of dimensions
      of the hemangioma based on direct measurement (in centimetres and length, width, height
      measurement).Small hemangiomas were measured using vernier calliper and others with measuring
      scale.

      Data was collected on follow up for both groups to confirm regression in size of hemangiomas
      and complications were noted. Single observer (resident pediatrician) saw the patients in
      each follow up and final outcome measured at 6th month. All this data was recorded on a
      Performa from 1st month to 6th month on monthly basis.

      Statically analysis Data was analyzed by using statistical package for social sciences (SPSS)
      version 23.0. Mean and standard deviation was calculated for qualitative variables like age,
      size at the baseline and at the follow up visit up till 6 month.

      Frequency and percentages were presented for qualitative data (sex, efficacy in terms of size
      of hemangioma). Chi square test was applied to compare efficacy of hemangioma in both groups
      at each visit. A P value < 0.05 was considered statistically significant. Effect modifiers
      like age, gender, duration and size of hemangioma were controlled by stratification.
    

Intervention name(s): Bleomycin
Intervention type(s): Drug
Other intervention name(s): Propranolol
Intervention MeSH terms: Bleomycin; Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Infantile Cutaneous hemangioma; Propranolol treatment; Bleomycin treatment; Efficacy