Severe exacerbation of asthma Respiratory Asthma
Conditions
Interventions
Children aged 2 - 5 years will be randomised to receive nebulised salbutamol 2.5 mg and ipratropium bromide 0.25 mg mixed with either 2.5 ml of isotonic magnesium sulphate (250 mmol/L, tonicity 289 mO
151 mg per dose) or 2.5 ml of isotonic saline on three occasions at twenty-minute intervals. Children 6 years and over will receive 5 mg of nebulised salbutamol.
Total duration of fol
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For children 6 years and older severe asthma is based on at least one of the following criteria being met: 1. Oxygen saturations less than 92% while breathing room air 2. Too breathless to talk 3. Heart rate greater than 120/min 4. Respiratory rate greater than 30/min 5. Use of accessory neck muscles For children aged 2 - 5 years of age, severe asthma is based on at least one of the following criteria being met: 1. Oxygen saturations less than 92% while breathing room air 2. Too breathless to talk 3. Heart rate greater than 130/min 4. Respiratory rate greater than 50/min 5. Use of accessory neck muscles
Exclusion criteria
Exclusion criteria: 1. Coexisting respiratory disease such as cystic fibrosis, chronic lung disease of prematurity 2. Severe renal disease 3. Severe liver disease 4. Known to be pregnant 5. Known to have had a reaction to magnesium previously 6. Parents who are unable to give informed consent 7. Previously randomised into MAGNETIC trial 8. Patients who present with life threatening symptoms 9. Previously involved with a trial of a medicinal product in the three months preceding screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Yung Asthma Severity Score (ASS) after 60 minutes of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical (during hospitalisation): 1. ?Stepping down? of treatment at one hour i.e. changed to having hourly treatment after the initial three, twenty-minute nebulisers 2. Number and frequency of additional salbutamol 3. Length of stay in hospital 4. Requirement for intravenous bronchodilator treatment 5. Intubation and/or admission to a Paediatric Intensive Care Unit (PICU) Patient outcomes at follow-up (1 month): 1. Paediatric Quality of Life Inventory (PedsQL™) asthma module parental report for all children and self-completion if aged over 5 years, European Quality of Life questionnaire (EQ-5D) 2. Time off school/nursery 3. Health care resource usage (e.g. General Practitioner [GP] visits, additional prescribing) Parent outcomes at follow-up (1 month): 1. Time off work (related to child?s illness) | — |
Countries
United Kingdom
Outcome results
None listed