Anabolic Steroid and Propranolol in Paediatric Burn

NCT05805553 | Unknown DMC

• 1 other identifier: 126/RC/KEMU
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Arrest; Bone; Development; Growth

Keywords

Pediatric; Burn; Propranolol; Steroid; Growth; arrest

Outcome Measures

Primary Outcomes (2)

• reversal of growth arrest

  BMI in kg/m\^2

  at 1 year after burn

• Bone mineral density measure

  Bone mineral density as g/cm\^2 (Z-score)

  at 1 year

Secondary Outcomes (1)

• no of blood transfusions

  at 60 days

Study Arms (3)

Group A

EXPERIMENTAL

Propranolol will be given to this group

Drug: Propranolol

group b

EXPERIMENTAL

steroid will be given

Drug: Nandrolone Decanoate

group c

EXPERIMENTAL

both propranolol and steroids will be given

Drug: Propranolol; Drug: Nandrolone Decanoate

Interventions

Propranolol DRUG

2mg/kg/day in 3-4 dividd doses

Group A; group c

Nandrolone Decanoate DRUG

1mg/kg weekly

group b; group c

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University, Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Burns

Interventions

Propranolol; Nandrolone Decanoate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nandrolone; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Azwa Janjua

CONTACT

03326223344; azwamunim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: April 10, 2023
• Study Start: December 1, 2020
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-03

Locations

PA (1)