Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?

Assiut University

Status and phase: Unknown; Phase 2

Conditions: Steroids In Management Of Acute Asthma Exacerbations

Treatments: Drug: Prednisolone Oral, Per 5 Mg; Drug: Dexamethasone 8Mg Solution for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03204760

Eman Alfy Ellia

Details and patient eligibility

About

The aim of this study is to compare the efficacy of a single dose of intramuscular dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to moderate asthma exacerbations in children and test whether this single dose of intramuscular dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM).

Full description

This study will be performed in Assiut university Children Hospital and will include patients with asthma exacerbations presented to the emergency department for three months. All children presenting to the emergency department with mild to moderate asthma exacerbations will be assessed to decide if the child needs treatment with salbutamol. Before starting treatment the Pediatric Respiratory Assessment Measure (PRAM), vital signs, and oxygen saturation will be recorded. Peak expiratory flow rate (PEFR) will also be recorded if the patient was 6 years or older.

Children with mild to moderate asthma exacerbation will be given the first dose of salbutamol and will be reassessed after 20 min by the emergency department attending. If further salbutamol is needed, subjects automatically will receive the second dose 20 min apart and receive either single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) or oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally .

A repeat physical examination will be performed, including oxygen saturation, vital signs, PRAM, PEFR after the 3rd dose of salbutamol and at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores. Patient compliance to prednisolone therapy for three days will be also recorded.

This study will be performed in Pediatric hospital - Assiut university and will include patients with asthma exacerbations presented to the emergency department for three months.

Enrollment: 50 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 2 to 16 years
• Background history of asthma
• Presentation with an asthma exacerbation requiring repeated salbutamol after 20 minutes.

Exclusion criteria

• Less than 2 years old or over 16 years
• Critical or life-threatening asthma
• Known tuberculosis exposure
• Active varicella or herpes simplex infection
• Documented concurrent infection with Respiratory syncytial virus
• Fever >39.5°C
• Use of oral corticosteroids in the previous four weeks
• Concurrent stridor
• Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

dexamethasone

Experimental group

Description:

Dexamethasone is a long-acting glucocorticoid with a half-life of 36 to 72 hours . It has been used safely in children with croup and bacterial meningitis . It is well absorbed both orally and parenterally .Single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg).

Treatment:

Drug: Dexamethasone 8Mg Solution for Injection

prednisolone

Experimental group

Description:

Prednisolone is relatively short acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Outpatient steroid therapy is effective once compliance is assured.. Prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance with prednisolone. Oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses .

Treatment:

Drug: Prednisolone Oral, Per 5 Mg