| Methods |
Randomisation: yes (table of random numbers)
Blinding: double‐blind
Number excluded: 13
Withdrawals: none
Baseline characteristics: Heart rate 127.8 (15.4 ) intravenous + nebulised group (iv), 146.2 (13.6) nebulised group; Respiratory rate 38.9 (11.9) iv, 45.8 (9.9) nebulised; glucose 7.5 (2.7) iv, 8.5 (3.1) nebulised; potassium 3.9 (0.5) iv, 4.2 (0.6) nebulised; pulmonary index 12 iv, 15 nebulised; accessory muscle use 12 iv, 15 nebulised; Dyspnea12 iv, 13 nebulised; wheeze 13 iv, 14 nebulised; fatigue 7 iv, 9 nebulised |
| Participants |
Location: Westmead, Australia
Participants: initially 50, 37 eligible, 29 final (8 gave no consent), 1‐12 yrs (mean 8.4 iv, 6.3 nebulised); males 7 iv, 12 nebulised; females 7 iv, 3 nebulised; height 1.3m (0.2) iv, 1.2m (0.2) nebulised; weight 29.2 kg (10.1) iv, 22.5 kg (8.1) nebulised
Asthma definition and severity: severe acute asthma as per National Australian Asthma Campaign guidelines
Exclusion criteria: mild, moderate or life‐threatening asthma, congenital heart disease,, family history or past episode of supraventricular tachycardia (SVT), respiratory illness, diabetes mellitus weighed < 10kg or > 50kg, aged < 12months or > 12yrs, or had already received the maximum iv dose for the day
Inhaled corticosteroid use: no details |
| Interventions |
Standard care: Coincident with iv drugs, O2 NPV 30%, continuous salbutamol 2.5 mg (< 2 yrs ) or 5 mg ( > 2 yrs ), hydrocortisone 5 mg/kg iv, then from 2 hrs onwards continuous salbutamol, then at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours depending on clinical state
Treatment group: salbutamol iv 15 ug/kg over 10 min at 0 min
Placebo: saline |
| Outcomes |
PFTs: not done
Timing: not done
Admissions: all patients admitted to high‐dependency ward
Side effects: higher proportion with tremor at 2 hours (specifics unknown)
Complications: |
| Notes |
Run in period of 30 min where patients given salbutamol nebulised of 2.5 or 5 mg |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomised by hospital pharmacy using a table of random numbers |
| Allocation concealment (selection bias) |
Low risk |
Investigators unaware as to order of randomisation sequence. Allocation sequence was retained by the pharmacy and released only when all clinical and laboratory assessments had been completed. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blind. Staff, investigators and patients were blinded and physicians who had administered the intravenous solution were surveyed to assess whether they had been aware of the solution being salbutamol or saline at the time of the bolus infusion and effective blinding was demonstrated. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Details of allocation released by pharmacy only when all clinical and laboratory assessments had been completed |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No patients withdrawn from trial |
| Selective reporting (reporting bias) |
Unclear risk |
No indication of reporting bias |
