Methods |
Design: parallel ‐ 2 arms
Country: Egypt
Method of randomisation: children were randomly assigned into 2 groups: Group A were given oral propranolol for 6 months combined with oral prednisolone for the initial 2 weeks, while Group B were given oral propranolol alone for 6 months.
Blinding: single‐blind/assessors
Location: Pediatric Surgery Department, Ain Shams University, Egypt
Length of follow‐up: 8 months
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Participants |
Diagnosis: cutaneous haemangioma causing complications such as deformity, ulceration, bleeding, infection, or damage of orifices
Sex: not stated
Age: between 4 weeks and 8 months
Inclusion criteria: the included participants had an age less than 9 months, with cutaneous haemangioma causing complications such as deformity, ulceration, bleeding, infection, or damage of orifices.
Exclusion criteria: congenital haemangioma, main/extensive deep subcutaneous component, those receiving previous treatment for IH or with hypersensitivity to propranolol, known cardiac disease (heart failure or AV block), pulmonary disease (asthma or bronchiolitis), diabetes mellitus, visceral haemangiomas, or PHACE syndrome
Number of randomised children: 40
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Interventions |
Intervention A (Number of children: 20): children were given oral propranolol dosed as 2 mg/kg/day in 3 divided doses for 6 months combined with oral prednisolone dosed as 2 mg/kg/day in 2 divided doses for the initial 2 weeks, then stopped after gradual tapering over 1 week. Propranolol was gradually tapered over 2 weeks before stopping.
Intervention B (Number of children: 20): children were given oral propranolol monotherapy in the same previous dose for 6 months.
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Outcomes |
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Notes |
Trial registration: not stated
Funder: not stated
Role of funder: not stated
A priori sample size estimation: not stated
Conducted: December 2011 to March 2014
Declared conflicts of interest: not declared
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "All patients were randomly assigned into one of the two groups at equal probability using sealed envelope method." Page 1504 Comment: Insufficient information to rate this item as low or high risk of bias. |
Allocation concealment (selection bias) |
Low risk |
Quote: "All patients were randomly assigned into one of the two groups at equal probability using sealed envelope method." Page 1504 Comment: Authors reported information about adequate allocation concealment. |
Blinding of participants (Performance bias) |
Unclear risk |
It is highly probable that participants were aware of intervention group assigned, but it is unclear whether this had an impact or not in trial results. |
Blinding of personnel (performance bias) |
Unclear risk |
It is highly probable that researchers were aware of intervention group assigned, but it is unclear whether this had an impact or not in trial results. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "Response to therapy was measured by blinded volume estimations at weeks (...)." Page 1504 Comment: Authors reported information about adequate blinding of outcome assessment. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No children were lost at follow‐up. |
Selective reporting (reporting bias) |
Low risk |
Selective reporting of information was not detected. |
Other bias |
Low risk |
No other biases were detected. |