Anabolic Steroid and Propranolol in Paediatric Burn

Not Applicable

Recruiting

• Conditions: Bone; Development; Growth; Arrest
• Interventions: Drug: Propranolol; Drug: Nandrolone Decanoate

• Registration Number: NCT05805553
• Lead Sponsor: King Edward Medical University

Brief Summary

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

Detailed Description

Burn is a major cause of morbidity and mortality worldwide; rate being seven times higher in low- and middle- income countries than high income countries. According to WHO, worldwide 11million people require medical attention secondary to burns. In Pakistan, 17% of burn patients have temporary disability while 18% suffer from a permanent disability Various studies have been done to improve patient outcome in terms of morbidity and mortality. Different medical interventions seem to have promising role in improving patient outcome in burn population.

Majority of pathological problems are due to catecholamines, an integral part of systemic metabolic drive, which increase approximately 10-fold as a response to injury . Hypermetabolic state has two aspects-the "ebb" and "flow" phases. The "ebb" phase lasts till first 48hours and has decreased metabolic rate and oxygen consumption while "flow" phase, which starts after resuscitation and has huge metabolic turnover, is the problematic one and needs intervention to decrease grave outcomes on patient's health. Systemic effects of catecholamines are significant once burned surface area increases more than 20% of the TBSA and persist for years . Various studies show that Propranolol and Oxandrolone have beneficial effects on decreasing morbidity and mortality in burn population Propranolol, a non-selective beta adrenergic blocker, has been used to minimize systemic effects of catecholamines and hypothetically results in anti-catabolic effects especially when given during ebb phase of the process i.e. decreases heart rate (HR) and blood pressure (BP) while during flow phase it increases hematocrit levels by increasing the renal erythropoietin secretion and decreases number of transfusions as well as blood loss during skin grafting "Herndon et al demonstrated that the cardiac effort was significantly reduced by 20% to 36% when the patients were given 2 mg/kg every 24 hours for 5 days. They determined that an ideal dose of 0.5 to 1.0 mg/kg intravenously every 6 to 8 hours should be given to adequately reduce left ventricular work without adversely affecting oxygen delivery or other cardiac functions" In another study done by Minifee et al, propranolol does not affect overall body delivery and consumption of oxygen but significantly decreases cardiac muscle requirement of oxygen . Moreover hyper-/hypo-glycemia, hypotension, azotemia, hypothermia, arrythmias and peripheral ischemia are also not observed as adverse effects . Another study by Baron et al showed that prolonged administration of oral or IV propranolol does not have an adverse effect on morbidity or mortality

Anabolic steroid (Oxandrolone/nandrolone) has a definite role in building up body's protein stores. Unlike testosterone, its adverse effects, acne, hirsutism, behavioral changes and liver functions are not documented, so they are considered safe. Use of oxandrolone alone and in combination with propranolol has a definitive effect as anti-catabolic agent and helps in better recovery and long-term outcomes on child's growth and decreases cardiac load.

A study done by Sylvia Ojeda et al at university of Texan in 2018 showed that propranolol is both safe and effective in managing the cardiovascular effects of hypermetabolic state in burn patients. A couple of other studies show that both propranolol and oxandrolone have a role in reducing the burden of disease in burn but data is lacking on effects of administration of both the drugs combined. Moreover, how the medication will affect our population is yet to be determined. This study will help us compare the effects of both drugs in our population and decrease the morbidity and mortality in burn patients.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-01-26
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group A	Propranolol	Propranolol will be given to this group
group b	Nandrolone Decanoate	steroid will be given
group c	Propranolol	both propranolol and steroids will be given
group c	Nandrolone Decanoate	both propranolol and steroids will be given

Primary Outcome Measures

Name	Time	Method
reversal of growth arrest	at 1 year after burn	BMI in kg/m\^2
Bone mineral density measure	at 1 year	Bone mineral density as g/cm\^2 (Z-score)

Secondary Outcome Measures

Name	Time	Method
no of blood transfusions	at 60 days	number of blood transfusions during hospital stay

Trial Locations

Locations (1)

King Edward Medical University, Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan