| Methods |
Design: parallel randomised controlled trial.
Method of randomisation: table of random numbers.
Concealment of allocation: not stated.
Blinding: double‐blinded, placebo‐controlled.
Withdrawals/dropouts: none described. |
| Participants |
Location: 1 paediatric emergency department in Detroit, Michigan.
Participants: 62 patients age 5 to 17, presenting to the emergency department with acute asthma exacerbation, FEV1 between 45% and 75% predicted.
Exclusions: Fever (> 39 °C), chronic disease (bronchopulmonary dysplasia, cystic fibrosis), known allergy to albuterol or magnesium, received any of steroids, theophylline or ipratropium bromide in the prior 3 days. |
| Interventions |
Treatment: albuterol 2.5 mg nebule with 2.5 mL isotonic MgSO₄ (6.3% solution); 1 dose.
Control: albuterol 2.5 mg nebule with 2.5 mL normal saline; 1 dose.
Both groups received corticosteroids (2 mg/kg) after inhaled treatment. |
| Outcomes |
Lung function (FEV1 and % predicted FEV1) at baseline, then at 10 and 20 minutes after treatment.
Also report vital signs and hospital admission rates.
State that none of the patients showed any side effects. |
| Notes |
Funding: this work was funded by an unrestricted grant from the Division of Pediatric Emergency Medicine, Children’s Hospital of Michigan, Detroit, Michigan |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
A table of random numbers was used to provide randomisation and this was performed by a senior research pharmacist at the institution. |
| Allocation concealment (selection bias) |
Low risk |
A table of random numbers was used to provide randomisation and this was performed by a senior research pharmacist at the institution. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blinded, placebo controlled. The study medications were provided in identical syringes and both the pharmacy and the investigator were blinded to their contents. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double‐blinded, placebo controlled. The study medications were provided in identical syringes and both the pharmacy and the investigator were blinded to their contents. Outcomes assessed at 10 and 20 minutes after treatment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
None described. |
| Selective reporting (reporting bias) |
Low risk |
All outcomes stated in the methods section are reported. |
