| Methods |
Design: randomised controlled trial.
Method of randomisation: unknown.
Concealment of allocation: yes.
Blinding: double‐blind, placebo‐controlled.
Solutions were pre‐packaged in identical appearing vials.
Withdrawals/dropouts: 3 participants were enrolled more than once, only the initial visit was used in the analysis. |
| Participants |
Location: emergency departments in 4 Argentinian hospitals.
Participants: 35 patients at least 18 years of age presenting to the emergency department with an acute asthma exacerbation who were able to have PEF measured were enrolled.
(% predicted PEF: 38 + 18 in treatment group, 38 + 12 in control group).
Exclusions: current smokers of ≥ 5 pack years, concurrent medical illness, pregnant, breast feeding, oral or parenteral steroids within the previous 7 days. |
| Interventions |
Standard of care: all patients received supplemental oxygen. If patient condition worsened patient may receive salbutamol 2.5 mg nebulised at discretion of physician.
Treatment: 0.5 mL salbutamol (2.5 mg) diluted in 3 mL isotonic MgSO₄ (286 mOsm, 7.5% = 225 mg).
Control: 0.5 mL salbutamol (2.5 mg) diluted in 3 mL normal saline.
Administration: jet nebulised using oxygen at 10 L/min via mouthpiece until dry. |
| Outcomes |
Measurements made at baseline, 10 minutes after treatment and 20 minutes after treatment.
Pulmonary functions: primary endpoint : % increase in peak flow = ((change/baseline) × 100).
Other: peak flow (best of 3 attempts).
Vital signs: respiratory rate, pulse rate, BP.
Duration of emergency room care.
No adverse events reported in either the experimental or control group. |
| Notes |
Funding: not reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomised. |
| Allocation concealment (selection bias) |
Unclear risk |
Information not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blind, placebo‐controlled. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double‐blind, placebo‐controlled. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
3 patients were enrolled more than once, only the initial visit was used in the analysis but treatment group not stated. |
| Selective reporting (reporting bias) |
High risk |
There were no significant differences between the groups in changes in BP, heart rate, or respiratory rate at either 10 minutes or 20 minutes. |
