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

NCT ID: NCT03204760

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-02-28

Brief Summary

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).

Detailed 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.

Conditions

Steroids In Management Of Acute Asthma Exacerbations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dexamethasone

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).

Group Type: EXPERIMENTAL

Dexamethasone 8Mg Solution for Injection

Intervention Type: DRUG

Effect single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) in the treatment of mild to moderate acute asthma exacerbations in children

prednisolone

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 .

Group Type: EXPERIMENTAL

Prednisolone Oral, Per 5 Mg

Intervention Type: DRUG

Effect of prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses in the treatment of mild to moderate acute asthma exacerbations in children.

Interventions

Dexamethasone 8Mg Solution for Injection

Effect single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) in the treatment of mild to moderate acute asthma exacerbations in children

Intervention Type: DRUG

Prednisolone Oral, Per 5 Mg

Effect of prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses in the treatment of mild to moderate acute asthma exacerbations in children.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman Alfy Ellia

Resident pediatrician , Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moustafa M. El-Saied, Ph.D.of pediatrics

Role: STUDY_CHAIR

Assiut University -Faculty of medecin( Pediaric department)

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Eman Alfy Ellia

Identifier Type: -

Identifier Source: org_study_id