Clinical trial
Role of Anabolic Steroid and Propranolol in Paediatric Burn- A Randomized Controlled Trial
Name
126/RC/KEMU
Description
propranolol and anabolic steroids have a role in pediatric burn patients and their combined effects are to be studied here. They decrease the catabolic response to burn trauma and minimize the duration of growth arrest hence improving the outcome
Trial arms
Trial start
2020-12-01
Estimated PCD
2023-09-28
Trial end
2023-09-28
Status
Recruiting
Treatment
Propranolol
2mg/kg/day in 3-4 dividd doses
Arms:
Group A, group c
Nandrolone Decanoate
1mg/kg weekly
Arms:
group b, group c
Size
114
Primary endpoint
reversal of growth arrest
at 1 year after burn
Bone mineral density measure
at 1 year
Eligibility criteria
Inclusion Criteria:
* Patients presenting within 48 hours of burn
* more than 20% and less than 40 %of TBSA burn (measured via modified rule of nine for pediatric burn according to age)
* age 2-12 years (as safety of anabolic steroids is not established in \<2years of age)
* Scald and flame burn
Exclusion Criteria:
* Diabetics (diagnosed before hospital admission)
* Renal disease (diagnosed before hospital admission)
* Asthmatics (on medication previously)
* Cardiac anomalies (previously diagnosed)
* Patients requiring cardiac support (norepinephrine, dobutamine at any dose and dopamine \>7ug/kg).
* All 4 limbs burnt
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Three groups are made. one will receive steroid (control group). other will receive propranolol and third will receive both propranolol and steroid. their results will be compared', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 114, 'type': 'ESTIMATED'}}
Updated at
2023-04-10
1 organization
2 products
4 indications
Organization
King Edward Medical UniversityProduct
PropranololIndication
ArrestIndication
BoneIndication
DevelopmentIndication
GrowthProduct
Nandrolone Decanoate