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. 2020 Dec 14;2020(12):CD012965. doi: 10.1002/14651858.CD012965.pub2

Modaresi 2015.

Study characteristics
Methods Trial registration: not traceable
Study design: double‐blind randomised clinical trial
Setting and centres: 3 hospitals paediatric departments, Isfahan University of Medical Sciences, Isfahan, Iran
Dates of study: January 2010 to December 2011
Duration of study: until child was discharged
Inclusion criteria: acute onset of respiratory distress, positive wheezing on physical examination, chest radiograph compatible with bronchiolitis, aged < 12 months, and RDAI score of at least 5
Exclusion criteria: family history of asthma; chronic pulmonary, cardiac, neurologic and oncologic disease; previous use of glucocorticoids, bronchodilators or monoamine oxidase inhibitors (MAOI); tachycardia exceeding 200 beats per minute; tachypnoea exceeding 100 breaths per minute
Participants Randomised: 125 infants. 2 study arms: magnesium sulphate + epinephrine 63; epinephrine 62
Analysed: magnesium sulphate + epinephrine 60; epinephrine 62. Three children in the magnesium sulphate + epinephrine group, and two children in the epinephrine group were subsequently withdrawn because of deteriorating clinical status
Analysis for follow‐up: there was no follow‐up of participants
Age: mean (SD) age was 5.2 (2.1) months in the magnesium sulphate + epinephrine group; 4.8 (3.2) months in the epinephrine group
Gender distribution: (male:female) was 34:26 in the magnesium sulphate + epinephrine group; 38:22 in the epinephrine group
Baseline clinical severity score: mean (SD) 11.4 (2.7) in the magnesium sulphate plus epinephrine group; 11 (2.7) in the epinephrine group
Baseline heart rate: mean (SD) 104 (5) in the magnesium sulphate + epinephrine group; 104 (4) in the epinephrine group
Baseline O₂ saturation: mean (SD) 88 (1) in the magnesium sulphate + epinephrine group; 87 (1) in the epinephrine group
Interventions Intervention: 40 mg/kg magnesium sulphate (3.25%) and 0.1 mL/kg epinephrine (1/1000) mixed with normal saline nebulisation
Comparator: 0.1 mL/kg epinephrine (1/1000) mixed with normal saline nebulisation
Concomitant treatment in both groups: 0.1 mL/kg epinephrine (1/1000) mixed with normal saline nebulisation
All groups received 3 doses of each medication at 20‐minute intervals, and then every 4 hours
Outcomes Planned outcomes: no protocol available
Reported outcomes: primary outcome was length of hospital stay (defined as the time from the first study inhalation until discharge from the hospital, as recorded in the medical record for each child). Other outcomes were
  1. RDAI scores;

  2. oxygen saturation;

  3. heart rate;

  4. respiratory rate; and

  5. use of ventilatory support.


All outcomes recorded at admission, first 20 minutes, second 20 minutes, third 20 minutes, after 4 hours, and then daily during hospitalisation
Notes Funding source: supported financially by Child Growth and Development Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Conflicts of interest: none
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk Adequate methods of sequence generation and allocation concealment used. Random number tables and third party randomisation were used
Blinding (performance bias and detection bias)
All outcomes Low risk Knowledge of allocations was never broken throughout the study, as stated by the trial authors
Incomplete outcome data (attrition bias)
All outcomes Low risk 3 children in the magnesium sulphate + epinephrine group and 2 children in the epinephrine group were subsequently withdrawn because of deteriorating clinical status
Selective reporting (reporting bias) Low risk The planned outcomes in the methods section were reported in the results section
Other bias Low risk None of the trial authors disclosed receipt of any grants, or funds, or shares from any pharmaceutical company. Authors reported no conflicts of interest