Sulfato de magnesio para el tratamiento de la bronquiolitis aguda en niños de hasta dos años de edad
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Trial registration: NCT02145520 Study design: randomised, double‐blind placebo‐controlled study Setting and centres: single‐centre, short stay unit, Paediatric Emergency Center, Hamad General Hospital, Qatar Dates of study: October 2012 to May 2015 Duration of study: until child discharged Inclusion criteria: children aged ≤ 18 months, with moderate to severe viral bronchiolitis, with prodromal history consistent with viral upper respiratory tract infection, followed by wheezing or crackles on auscultation, or both, and a Wang bronchiolitis severity score ≥ 4 on presentation Exclusion criteria: children were excluded if they had 1 or more of the following characteristics: preterm birth ≤ 34 weeks' gestation, previous history of wheezing, steroid use within 48 hours of presentation, obtundation and progressive respiratory failure requiring intensive care unit admission, history of apnoea within 24 hours before presentation, oxygen saturation ≤ 85% on room air, history of a diagnosis of chronic lung disease, congenital heart disease, immunodeficiency, exposure to varicella within 21 days before enrolment, known magnesium or calcium metabolism disturbance, or known adverse reaction to magnesium sulphate | |
| Participants | Randomised: 162 infants; 80 in the magnesium group and 82 in the placebo group. Analysed: 160 infants; 78 in the magnesium group and 82 in the placebo group; 2 enrolled infants could not be included in the analysis: 1 was immunodeficient and 1 was discharged against medical advice Analysis for follow‐up: at 2 weeks: 158 infants; magnesium 77; placebo 81 (2 children were lost to follow‐up, 1 from each group) Age: (mean (SD)) was 4 (3) months in the magnesium group and 5 (4) months in the placebo group Gender distribution: (male: female) was 58:22 in the magnesium group and 48:34 in the placebo group Baseline Wang bronchiolitis severity score: mean (SD) was 6.85 (1.30) in the magnesium group and 6.97 (1.17) in the placebo group | |
| Interventions | Intervention: 100 mg/kg magnesium sulphate intravenously by a syringe pump over 60 minutes; single dose Comparator: placebo; 0.9% saline Concomitant treatment in both study arms: 5 mL nebulised 5% hypertonic saline in 1 mL 1:1000 epinephrine given at 4 hour intervals throughout the infirmary stay | |
| Outcomes | Planned outcomes: the study protocol was available, so we could determine the planned outcomes. Primary outcome was improvement percentage of discharge after a dose of intravenous magnesium sulphate (time frame: time to medical readiness for discharge). Secondary outcomes were
Reported outcomes: all outcomes planned in study protocol were reported in the paper. Outcome data not provided in a usable way for improvement percentage of discharge after a dose of intravenous magnesium sulphate. Study authors used geometric mean (95% CI) time until discharge and expressed results as ratio of geometric mean time in 2 interventions. Mean (SD) was not provided by the authors. | |
| Notes | Funding source: this study was hospital sponsored by Hamad Medical Corporation Conflicts of interest: none Comment: the study did not provide mean and standard deviations for clinical severity score at various time points. They included a bar chart from which it was difficult to obtain the exact scores. The trial author provided this information in the form of a table. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Adequate methods of sequence generation and allocation concealment used. "Randomisation was stratified into two groups, patients with a history of eczema and/or known to have a parent or full sibling with prior physician diagnosis of asthma, and patients without. Block randomisation was used for allocation". |
| Blinding (performance bias and detection bias) | Unclear risk | Details of blinding were not mentioned |
| Incomplete outcome data (attrition bias) | Low risk | Only 1 child was lost to follow‐up in either group, and excluded from analysis |
| Selective reporting (reporting bias) | Low risk | Outcomes planned in the protocol were reported in the published report |
| Other bias | Low risk | None of the trial authors disclosed receipt of any grants, funds, or shares from any pharmaceutical company. Authors reported no conflicts of interest |
| Study characteristics | ||
| Methods | Trial registration: not traceable Study design: double‐blind, prospective clinical trial Setting and centres: single‐centre, short‐stay unit, Pediatric Emergency Department of Erciyes University Hospital, Central Anatolia, Kayseri, Turkey Dates of study: October 2012 to March 2013 Duration of study: until child was discharged Inclusion criteria: children aged 1 to 24 months, history of preceding viral upper respiratory infection followed by wheezing and crackles on auscultation, first wheezing episode, and clinical severity score 4 to 8 on admission. Viral respiratory infection was diagnosed on clinical grounds. Exclusion criteria: infants with clinical severity score < 4 or > 8, oxygen saturation (SaO₂) < 86 % in room air, chronic cardiopulmonary or neurological disease, premature birth, birthweight < 2500 g, history of recurrent wheezing episodes, history of atopy, proven immune deficiency, age < 1 month or > 2 years, proven or suspected acute bacterial infection, previous treatment with bronchodilators or corticosteroids, the presence of symptoms > 7 days, proven asthma in parents and siblings, and consolidation or atelectasis on a chest roentgenogram | |
| Participants | Randomised: 57 infants Analysed: 56 infants; magnesium 19; salbutamol 18; salbutamol plus magnesium sulphate 19 (1 child in the magnesium sulphate group subsequently withdrew because of deteriorated clinical status Analysis for follow‐up: there was no follow‐up of participants Age: median age (min to max) was 7.5 (3 to 19) months in the salbutamol group; 8 (4 to 22) months in the magnesium sulphate group; and 8 (3 to 21) months in the salbutamol + magnesium sulphate group Gender distribution (male:female) was 12:6 in the salbutamol group; 12:7 in the magnesium sulphate group; and 13:6 in the magnesium sulphate + salbutamol group Baseline clinical severity score: mean (95% CI) clinical severity score was 5.9 (5.4 to 6.4) in the salbutamol group; 6.1 (5.6 to 6.5) in the magnesium sulphate group; and 6.3 (5.7 to 6.8) in the salbutamol + magnesium sulphate group Baseline heart rate: mean heart rate was 149.4 (95% CI 136.9 to 161.8) in the salbutamol group; 147.8 (95% CI 139.4 to 156.1) in the magnesium sulphate group; and 156.7 (95% CI 149.2 to 165.2) in the salbutamol + magnesium sulphate group | |
| Interventions | Intervention: inhaled magnesium sulphate 150 mg, diluted to 4 mL with 0.9 % saline solution Comparator:
All groups received medications twice, at 30‐minute intervals | |
| Outcomes | Planned outcomes: no protocol available Reported outcomes: main outcomes were:
Outcome data not provided in a usable way for duration of hospital stay. Authors used mean (95% CI) time and expressed result as P value for significance comparing two interventions. Mean (SD) was not provided by the trial authors | |
| Notes | Funding source: not mentioned | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | "All eligible patients were randomly assigned to one of the three groups". Details of randomisation method, or how randomisation was done were not available |
| Blinding (performance bias and detection bias) | Unclear risk | The trial report mentioned double‐blinded study, but did not report for whom, or how double‐blinding was conducted |
| Incomplete outcome data (attrition bias) | Low risk | 1 child in the magnesium sulphate group subsequently withdrew because of deteriorating clinical status. This was unlikely to affect results |
| Selective reporting (reporting bias) | Low risk | The planned outcomes in the methods section were reported in the results section |
| Other bias | Unclear risk | Source of funding not mentioned |
| 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
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) | Low risk | Knowledge of allocations was never broken throughout the study, as stated by the trial authors |
| Incomplete outcome data (attrition bias) | 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 |
| Study characteristics | ||
| Methods | Trial registration: not traceable Study design: single‐blind randomised controlled trial Setting and centres: single‐centre, emergency department, paediatric intensive care unit and wards of Institute of Social Paediatrics, Stanley Medical College and Hospital, Tamilnadu, India. Dates of study: January 2017 to September 2017 Duration of study: until child was discharged Inclusion criteria: children less than 12 months old, with acute onset of respiratory symptoms associated with fever, cough, tachypnoea, or chest radiograph findings consistent with bronchiolitis (such as hyperinflation), and first episode of wheezing Exclusion criteria: previous history of wheezing
| |
| Participants | Randomised: 220 infants. 2 study arms: nebulised magnesium sulphate 110; nebulised hypertonic saline 110 Analysed: magnesium sulphate 110; hypertonic saline 110. No missing data. Analysis for follow‐up: none Age: the mean (SD) age was 7.1 (3.1) months in the magnesium sulphate group; 6.9 (3) months in the hypertonic saline group. Gender distribution: (male:female) 63:47 in the magnesium sulphate group; 63:47 in the hypertonic saline group. Baseline clinical severity score (RDAI): mean (SD) 8.0 (1.8) in the magnesium sulphate group; 7.9 (1.7) in the hypertonic saline group | |
| Interventions | Intervention: magnesium sulphate; 0.1 to 0.2 mL/kg/dose of 25% magnesium sulphate, mixed to 4 mL with 0.9% normal saline nebulisation Comparator: 4 mL hypertonic saline nebulisation All children received medications at 20‐minute intervals for the first 3 doses, and then every 4 hours Concomitant treatment in both groups: none mentioned | |
| Outcomes | Planned outcomes: no protocol available Reported outcomes:
| |
| Notes | Funding source: not mentioned Conflicts of interest: not mentioned | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | Deatails of randomisation not available. Sealed envelopes used, but it is not known whether these were sequentially numbered and opaque |
| Blinding (performance bias and detection bias) | Unclear risk | Authors reported the study to be single‐blinded, but due to unclear allocations, blinding method was not robust |
| Incomplete outcome data (attrition bias) | Low risk | There were no dropouts |
| Selective reporting (reporting bias) | Low risk | The planned outcomes in the methods section were reported in the results section |
| Other bias | Unclear risk | Details related to source of funding and the conflicts of interests were not shared. |
CI: confidence interval
SD: standard deviation
RDAI: respiratory distress assessment instrument
min: minimum
max: maximum
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| The study was published as a conference abstract. It included children presenting with first or second episodes of moderate to severe acute bronchiolitis. Trial authors responded, but could not provide additional data related to first episodes of bronchiolitis (inclusion criteria for this review). | |
| Study population did not match the review inclusion criteria. Trial authors included children with more than one episode of wheezing, while inclusion eligibility was limited to children with first episode of wheezing in this review, as per the definition by AAP Subcommittee 2006. | |
| This study included children with a wheezy chest from all causes, which is not part of our inclusion criteria. The trial authors stated that they included infants and children between 2 months and 12 years. However, the trial authors could not provide details of outcomes on children up to 2 years of age, which was part of our inclusion criteria for this review. |
Characteristics of ongoing studies [ordered by study ID]
| Study name | CTRI/2017/02/007919 |
| Methods | Trial registration: CTRI/2017/02/007919 Study design: randomised, parallel‐group, placebo‐controlled trial Setting and centres: single centre, emergency department, Department of Paediatrics, GMSH, Chandigarh, India Dates of study: first enrolment 12 January 2017 Duration of study: intervention duration: 3 hour; outcome assessment duration: until child was discharged Inclusion criteria: children aged 2 to 12 months with diagnosis of acute bronchiolitis, with short history of cough, with or without fever of less than 7 days duration, wheezing on examination, first attack of wheezing. Exclusion criteria: past history of wheezing, family history of bronchial asthma, presence of congenital heart disease or congenital malformation, history of prematurity or mechanical ventilation in newborn period, pneumonia or pleural effusion, SAM, very sick child with shock, seizures, tachycardia (HR > 200/minute), and respiratory failure, foreign body ingestion, history of nebulisation of any drug |
| Participants | Plan to randomise 104 infants |
| Interventions | Intervention: magnesium sulphate nebulisation: enrolled cases in the intervention group shall be given 40 mg/kg magnesium sulphate nebulisation, diluted with 2 mL to 3 mL normal saline. 3 doses of medication will be given at 1‐hour intervals, and will not be repeated after 3 doses Comparator: oxygen therapy, IV fluids or oral feeds: this group will be treated with oxygen therapy, IV fluids, or oral feeds, symptomatic treatment for fever, and supportive care Concomitant treatment in both study arms: none written |
| Outcomes | Primary outcomes: improvement in severity of bronchiolitis, measured with the Respiratory Distress Assessment Instrument (RDAI) score. Timepoint: RDAI score shall be assessed at admission, at 3, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96 hours, and at discharge. Secondary outcomes:
|
| Starting date | 12 January 2017 |
| Contact information | Name: Dr Neeraj Dhawan Email: [email protected]; [email protected] Address: Department of Paediatrics, Government Multispeciality Hospital, Chandigarh, India |
| Notes |
| Study name | CTRI/2018/06/014400 |
| Methods | Trial registration: CTRI/2018/06/014400 Study design: randomised, parallel‐group, placebo‐controlled trial Setting and centres: single centre in India Dates of study: first enrolment 2 July 2018 Duration of study: interventions: 24 hours; follow‐up: 2 weeks Inclusion criteria: infants aged 1 month to 24 months presenting to paediatric emergency or OPD, with diagnosis of bronchiolitis and BSS ≥ 4, and guardian of child willing to give informed consent Exclusion criteria:
|
| Participants | Randomised: plan to randomise 50 Infants Analysed: not available Analysis for follow‐up at 2 weeks: not available Age: infants 1 month to 24 months of age Gender distribution: not available Baseline Wang bronchiolitis severity score: > 4 |
| Interventions | Intervention: nebulisation with 3 mL 3.2% magnesium sulphate every 4 hours for 24 hours, in addition to standard care. Oxygen saturation will be noted before starting treatment, and oxygen will be supplemented if < 92%. If the saturation falls below 90% in either group, and persists despite oxygen supplementation, the child will be considered for ventilation. Comparator: standard care: maintenance of adequate hydration and oxygenation Concomitant treatment in both study arms: none written |
| Outcomes | Primary outcomes: to compare improvement of bronchiolitis severity scores between treatment groups. Secondary outcomes:
|
| Starting date | 12 January 2017 |
| Contact information | Name: Dr Daisy Khera Email [email protected] Department of Pediatrics AIIMS Jodhpur, Jodhpur, Rajasthan, India |
| Notes |
OPD: out patient department
BSS: bronchiolitis severity score
SAM: severe acute malnutrition
SpO₂: Oxygen saturation
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Clinical severity score at 0 to 24 hours after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 1.1  Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 1: Clinical severity score at 0 to 24 hours after treatment | ||||
| 1.2 Clinical severity score at 25 to 48 hours after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 1.2  Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 2: Clinical severity score at 25 to 48 hours after treatment | ||||
| 1.3 Hospital readmission rate within 30 days of discharge Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Analysis 1.3  Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 3: Hospital readmission rate within 30 days of discharge | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Duration of hospital stay Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 2.1  Comparison 2: Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children, Outcome 1: Duration of hospital stay | ||||
| 2.2 Clinical severity score at 25 to 48 hours after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 2.2  Comparison 2: Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children, Outcome 2: Clinical severity score at 25 to 48 hours after treatment | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Duration of hospital stay Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 3.1  Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 1: Duration of hospital stay | ||||
| 3.2 Clinical severity score at 0 to 24 hour after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 3.2  Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 2: Clinical severity score at 0 to 24 hour after treatment | ||||
| 3.3 Clinical severity score at 25 to 48 hour after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 3.3  Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 3: Clinical severity score at 25 to 48 hour after treatment | ||||
Study flow diagram
'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study
'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item, presented as percentages across all included studies
Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 1: Clinical severity score at 0 to 24 hours after treatment
Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 2: Clinical severity score at 25 to 48 hours after treatment
Comparison 1: Magnesium sulphate compared with placebo for acute bronchiolitis in children, Outcome 3: Hospital readmission rate within 30 days of discharge
Comparison 2: Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children, Outcome 1: Duration of hospital stay
Comparison 2: Magnesium sulphate compared with hypertonic saline for acute bronchiolitis in children, Outcome 2: Clinical severity score at 25 to 48 hours after treatment
Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 1: Duration of hospital stay
Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 2: Clinical severity score at 0 to 24 hour after treatment
Comparison 3: Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine for acute bronchiolitis in children, Outcome 3: Clinical severity score at 25 to 48 hour after treatment
| Magnesium sulphate versus placebo for acute bronchiolitis in children | ||||||
|---|---|---|---|---|---|---|
| Patient or population: children up to 18 months old with acute bronchiolitis Settings: short stay unit, paediatric emergency department Intervention: magnesium sulphate Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Certainty of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Magnesium sulphate | |||||
| Time to recovery | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Mortality | See comment | See comment | Not estimable | 160 | See comment | Trial authors confirmed there were no deaths in either group (personal communication) |
| Adverse events | See comment | See comment | Not estimable | 160 | See comment | Neither group reported adverse effects, such as apnoea, cyanosis, or haemodynamic instability |
| Duration of hospital stay | Geometric mean time to discharge was 25.3 hours in the placebo group. | Geometric mean time to discharge was 24.1 hours in the magnesium sulphate group. | Not estimable | 160 | See comment | Results were taken directly from the published report. |
| Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) | The mean (SD) CSS at 24 hours in the placebo group was 4.55 points (1.62) | The mean CSS at 24 hours in the magnesium sulphate group was 0.13 points higher (0.28 lower to 0.54 higher) | MD 0.13, (‐0.28 to 0.54) | 160 | ⊕⊝⊝⊝ very lowa | |
| Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) | The mean (SD) CSS at 48 hours in the placebo group was 4.84 points (1.57) | The mean CSS at 48 hours in the magnesium sulphate group was 0.42 points lower (0.84 lower to 0) | MD ‐0.42, (‐0.84 to ‐0.00) | 160 | ⊕⊝⊝⊝ very lowa | |
| Hospital re‐admission within 30 days of discharge (re‐admissions were reported at 14 days) | 62 per 1000 | 195 per 1000 | RR 3.16 | 158 | ⊕⊕⊝⊝ | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded the quality of the evidence to very low for indirectness and very serious imprecision (1 study, small sample size, wide confidence intervals). | ||||||
| Magnesium sulphate versus hypertonic saline for acute bronchiolitis in children | ||||||
|---|---|---|---|---|---|---|
| Patient or population: children up to 12 months old with acute bronchiolitis Settings: single‐centre, emergency department, paediatric intensive care unit and wards Intervention: magnesium sulphate Comparison: hypertonic saline | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Certainty of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Hypertonic saline | Magnesium sulphate | |||||
| Time to recovery | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Mortality | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Adverse events | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Duration of hospital stay | The mean (SD) duration of hospital stay in the hypertonic saline group was 3.2 days (1.0) | The mean duration of hospital stay in the magnesium sulphate group was 3.2 days (0.28 lower to 0.28 higher) | MD 0.00 (‐0.28 to 0.28) | 220 (1 RCT) | ⊕⊝⊝⊝ | |
| Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured at 0 to 24 hours | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured at 25 to 48 hours | The mean (SD) CSS at 48 hours in the hypertonic saline group was 3.7 points (1.8) | The mean CSS at 48 hours in the magnesium sulphate group was 0.10 points higher (0.39 lower to 0.59 higher) | MD 0.10 (‐0.39 to 0.59) | 220 | ⊕⊝⊝⊝ | |
| Hospital re‐admission within 30 days of discharge | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded the quality of the evidence to very low for indirectness and very serious imprecision (1 study, small sample size). | ||||||
| Magnesium sulphate or magnesium sulphate + salbutamol versus salbutamol for acute bronchiolitis in children | ||||||
|---|---|---|---|---|---|---|
| Patient or population: children from 1 month to 24 months old with acute bronchiolitis Settings: single‐centre, short‐stay unit, paediatric emergency department Intervention: magnesium sulphate or magnesium sulphate + salbutamol Comparison: salbutamol | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Certainty of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Salbutamol | Magnesium sulphate or magnesium sulphate + salbutamol | |||||
| Time to recovery | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Mortality | See comment | See comment | Not estimable | 56 | ‐ | No deaths occurred in any of the groups (personal communication) |
| Adverse events | See comment | See comment | Not estimable | 56 | ‐ | There were no instances of adverse effects, such as hypotension, arrhythmias, or loss of deep tendon reflexes reported in any of the groups. |
| Duration of hospital stay | The mean duration of hospital stay in the salbutamol group was 24 hours (95% CI 23.4 to 76.9). | The mean duration of hospital stay in the magnesium sulphate group was 24 hours (95% CI 25.8 to 47.4). The mean duration of hospital stay for the magnesium sulphate + salbutamol group was 20 hours (95% CI 15.3 to 39.0). | Not estimable | 56 | ‐ | Results were taken directly from the published report. |
| Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) measured at 0 to 24 hours | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Clinical severity score (CSS) (Wang score; range 0 to 12; higher = poorer outcome) measured 25 to 48 hours | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Hospital re‐admission within 30 days of discharge | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| a3‐arm trial: magnesium sulphate group (19 children), magnesium sulphate plus salbutamol (19 children), salbutamol (18 children) | ||||||
| Magnesium sulphate + epinephrine versus no treatment or normal saline + epinephrine | ||||||
|---|---|---|---|---|---|---|
| Patient or population: children up to 12 months old with acute bronchiolitis Settings: 3 paediatric departments of 3 hospitals Intervention: magnesium sulphate + epinephrine Comparison: no treatment or normal saline + epinephrine | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Certainty of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| no treatment or normal saline + epinephrine | Magnesium sulphate + epinephrine | |||||
| Time to recovery | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Mortality | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Adverse events | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| Duration of hospital stay | The mean (SD) duration of hospital stay in the epinephrine group was 84.7 hours (10.1) | The mean (SD) duration of hospital stay for the magnesium sulphate + epinephrine group was 0.40 hours less (3.94 lower to 3.14 higher) | MD ‐0.40 (‐3.94 to 3.14) | 120 | ⊕⊝⊝⊝ | |
| Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured at 0 to 24 hours | The mean (SD) CSS at 24 hours in the epinephrine group was 6.6 points (2.2) | The mean CSS at 24 hours in the magnesium sulphate + epinephrine group was 0.20 points lower (1.06 lower to 0.66 higher) | MD ‐0.20 (‐1.06 to 0.66) | 120 | ⊕⊝⊝⊝ | |
| Clinical severity score (CSS) (RDAI score; range 0 to 17; higher = poorer outcomes) measured 25 to 48 hours | The mean (SD) CSS at 48 hours in the epinephrine group was 3.7 points (2.7) | The mean CSS at 48 hours in the magnesium sulphate + epinephrine group was 0.90 points lower (1.75 lower to 0.05 lower) | MD ‐0.90 (‐1.75 to ‐0.05) | 120 | ⊕⊝⊝⊝ | Higher value indicates poor outcome |
| Hospital re‐admission within 30 days of discharge | ‐ | ‐ | ‐ | ‐ | ‐ | Outcome not measured |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded the evidence to very low for indirectness and very serious imprecision (1 study, small sample size). | ||||||
| Outcome | Comparison | Reason for not conducting analysis |
|---|---|---|
| Time to recovery | All comparisons | No data available |
| Mortality | Magnesium sulphate compared with placebo | No deaths reported |
| magnesium sulphate compared with conventional bronchodilator | ||
| Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator | ||
| Magnesium sulphate compared with hypertonic saline | No data available | |
| Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine | ||
| Adverse effects of magnesium sulphate treatment | Magnesium sulphate compared with placebo | No adverse effects reported |
| Magnesium sulphate compared with conventional bronchodilator | ||
| Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator | ||
| Magnesium sulphate compared with hypertonic saline | No data available | |
| Magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine | ||
| Duration of hospital stay | Magnesium sulphate compared with placebo | Reporting format was different. Study authors used geometric mean timea. We did not transform data for analysis, as only single study was available for this comparison. |
| Magnesium sulphate compared with conventional bronchodilator | Reporting format was different. Study authors used 95% confidence interval. We did not transform data for analysis, as only single study was available for this comparison. | |
| Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator | ||
| Clinical severity score at 0 to 24 hours after treatment | Magnesium sulphate compared with hypertonic saline | No data available |
| Magnesium sulphate compared with conventional bronchodilator | ||
| Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator | ||
| Clinical severity score at 25 to 48 hours after treatment | Magnesium sulphate compared with conventional bronchodilator | No data available |
| Magnesium sulphate + bronchodilator compared with no treatment or normal saline + the same bronchodilator | ||
| Pulmonary function test | All comparisons | No data available |
| Hospital readmission rate within 30 days of discharge | All comparisons except magnesium sulphate compared with placebo | No data available |
| Duration of mechanical ventilation | All comparisons | No data available |
| Duration of intensive care unit stay | All comparisons | No data available |
| Note: these analyses were planned in the protocol, but were not carried out due to limited or no available data. aGeometric mean is equal to the exponential of the mean of the log‐transformed values. The value of geometric mean is usually lesser than the arithmetic mean. Geometric mean is used as it is not much affected by the skewed distribution of data. | ||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Clinical severity score at 0 to 24 hours after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.2 Clinical severity score at 25 to 48 hours after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 1.3 Hospital readmission rate within 30 days of discharge Show forest plot | 1 | Risk Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Duration of hospital stay Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 2.2 Clinical severity score at 25 to 48 hours after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Duration of hospital stay Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 3.2 Clinical severity score at 0 to 24 hour after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 3.3 Clinical severity score at 25 to 48 hour after treatment Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
