The Office of Evidence Based Practice, 2011 Center of Clinical Effectiveness. Importance. Quality. No of studies

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1 Question 6: In the child with asthma exacerbation in the ED should magnesium sulfate IV be used prevent hospitalization, decrease time in the ED, and improve pulmonary function? GRADEprofiler Table: Rowe BH, Bretzlaff J, Bourdon C, Bota G, Blitz S, Camargo CA.( 2000). Magnesium sulfate for treating exacerbations of acute asthma in the emergency department. Cochrane Database of Systematic Reviews, Issue 1. Art. No.: CD DOI: / CD Summary of findings Quality assessment No of patients Effect Relative No of Other IV Design Limitations Inconsistency Indirectness Imprecision studies considerations magnesium control (95% Absolute CI) Admission- Severe Group (follow-up 2-15 hours 1 ; admission) 4 2,3,4,5 randomized none OR /70 57/63 (0.07 to (48.6%) (90.5%) 0.3) 334 fewer per 1000 (from 165 fewer to 505 fewer) Pulmonary Function % predicted (follow-up median 2-15 hours 1 ; measured with: % predicted FEV1; Better indicated by higher values) 3 2,3,6 randomized serious 7 serious 8 none MD 4.33 lower ( trials limitations indirectness lower to 2.3 higher) 9 Pulmonary Function Absolute PEF (follow-up 2-15 hours 1 ; Better indicated by higher values) 5 3,5,6,10,11 randomized serious 8 none MD 29.4 lower (62.2 trials limitations 11 inconsistency indirectness lower to 3.4 higher) 9 Quality HIGH LOW Importance MODERATE Duration in the ED (follow-up 2-15 hours 1 ; measured with: time; Better indicated by lower values) 2 4,11 randomized serious 8 none trials limitations inconsistency indirectness Pulmonary Function severe group % predicted FEV1 (follow-up 2-15 hours 1 ; Better indicated by higher values) 3 2,3,6 randomized none Pulmonary Function severe group absolute PEF (follow-up hours; Better indicated by higher values) 3 randomized none Pulmonary Function severe absolute FEV1 (follow-up < 15 hours; Better indicated by higher values) MD 5.28 lower (9.34 to 1.21 lower) MD 9.81 lower (15.82 to 3.8 lower) 9 HIGH MD lower (77.5 to 27 lower) 9 HIGH MODERATE 19

2 1 4 randomized trials limitations inconsistency indirectness imprecision none MD 17 lower (22.76 to lower) 9 HIGH 1 The range is the time after admission to the ED when assessments of subjects who were enrolled in the study began. In all studies, subjects who were too ill to receive at least 3 SABA treatments were not randomized to the magnesium study. Three of the four studies starting assessing for admission at 2 hours after being in the ED (or 1 hour after Mg administration) and made the decision to admit within 4 hours. The Devi (1997) assessed patients out to 15 hours. The timing of the admission assessment was not described in this study. 2 Bloch Ciarallo 1997 Pediatric study 4 Devi 1997 Pediatric study 5 Skobeloff Silverman I squared stat 73% 8 Estimate of effect includes zero. 9 For the measurement of effect of all pulmonary functions in this review better is indicated by lower numbers. All measures are the difference between the baseline value and the treated value. As difference between the treated value and the base line value becomes more negative as the the treatment value becomes greater. 10 Tiffany Green 1992 did not blind Synthesis Author: EBP Scholar (Allen, N H.) Forest Plot of Single Studies since EPR-3 (2007) Effect of IV Magnesium added to Standard Therapy, outcome: %FEV1 at 120 minutes. Study or Subgroup Favours experimental Control-standard care Mean Difference Mean Difference Mean SD Mean 56.7 SD 6.2 Weight IV, Fixed, 95% CI 6.14 [1.92, 10.36] IV, Fixed, 95% CI (95% CI) Heterogeneity: Not applicable Test for overall effect: Z = 2.85 (P = 0.004) Effect of IV Magnesium added to Standard Therapy, outcome: Hospitalization 6.14 [1.92, 10.36] Favours control Favours experimental 20

3 Study or Subgroup Favours experimental Control-standard care Odds Ratio Odds Ratio Events 2 Events 9 Weight M-H, Fixed, 95% CI 0.17 [0.03, 0.85] M-H, Fixed, 95% CI (95% CI) events 2 Heterogeneity: Not applicable Test for overall effect: Z = 2.15 (P = 0.03) [0.03, 0.85] Favours experimental Favours control Synthesis Author: EBP Scholars (Allen, N.H., Bartlett, J. A., Dusin, J. D., Gordon, B., Hodges, K., Newman, R. E., Pirvu, D., & Shubat, S. J.) Risk of bias summary figure: Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding (performance bias and detection bias) Incomplete outcome data (attrition bias) Selective reporting (reporting bias) Other bias?? Included Single Study Characteristics and Risk of Bias Tables: Characteristics of included study: Methods placebo controlled, randomized single blind Participants Adults years of age with acute asthma as evidenced by FEV1 < % predicted, willing to remain in the ED for 3 hours and 21

4 fulfilled most of the criteria for severe asthma according to the GINA criteria. Interventions Group A (IV MgSO4 group): Patients received 1 ml of 2.5% salbutamol (2.5 mg), 250 micrograms of 1.5 ml ipratropium administered in 2.5 ml of normal saline via wet nebulizer with 100% oxygen at 0,20,40 minutes after admission into the protocol. At min, the patient received 2 g magnesium sulphate in 250 ml of normal saline solution given slowly over 20 minutes. Group B (control group): Patients received 1 ml of 2.5% salbutamol (2.5 mg), 250 micrograms of 1.5 ml ipratropium administered in 2.5 ml of normal saline via wet nebulizer with 100% oxygen at 0,20,40 minutes after admission into the protocol. At min, the patient received like-appearing placebo in 250 ml of normal saline solution. Outcomes Primary: % predicted FEV1 at 120 minutes. Secondary: Admission to the hospital Notes Excluded: History of COPD or other chronic lung disease, known cardiac, renal, or hepatic dysfunction, pregnant or lactating, Patients unable to perform spirometry or those who required intubation. Power was calculated to detect a 0.32 L difference in FEV1 and a 15% difference in hospital admissions at 80% power. Risk of bias: Bias Scholars judgment Support for judgment Random sequence generation (selection bias) Low risk Random numbers table, 1:1 randomization table Allocation concealment (selection bias) Unclear risk Envelope concealment, until patient was included in the assigned group. Blinding (performance bias and detection bias) Unclear risk Not sure who was blinded in the ED, however the staff making the decision to discharge or admit the subject was blinded. Incomplete outcome data (attrition bias) Low risk 75 screened, 5 excluded, 10 protocol violations. Selective reporting (reporting bias) Low risk Other bias Low risk Synthesis Author: EBP Scholar (Allen, N H.) Search Strategy: PubMed search September 16, 2010 (("Asthma"[Mesh] AND ("Emergency Service, Hospital"[Mesh] OR "Emergency Nursing"[Mesh] OR "Emergency Medical Services"[Mesh] OR "Emergency Medicine"[Mesh] OR "Acute Disease"[Mesh] OR exacerbation[all Fields] OR attack[all Fields])) AND ("Magnesium Sulfate"[Mesh] OR "heliox "[Substance Name] OR "Continuous Positive Airway Pressure"[Mesh] OR "Epinephrine"[Mesh] OR "Terbutaline"[Mesh] OR "zafirlukast "[Substance Name] OR "zileuton "[Substance Name] OR "montelukast "[Substance Name] OR "Receptors, Leukotriene"[Mesh] OR "Leukotriene Antagonists"[Mesh] OR "methylxanthine "[Substance Name] OR "Phosphodiesterase Inhibitors"[Mesh] OR "Theophylline"[Mesh] OR "Aminophylline"[Mesh])) AND ("humans"[mesh Terms] AND ((Meta-Analysis[ptyp] OR Practice Guideline[ptyp] OR Randomized Controlled Trial[ptyp] OR Guideline[ptyp]) OR ("Cohort Studies"[Mesh] OR "Epidemiologic Studies"[Mesh] 22

5 OR systematic[sb])) AND English[lang] AND ("infant"[mesh Terms] OR "child"[mesh Terms] OR "adolescent"[mesh Terms])) AND ("2006/03"[PDAT] : "2010"[PDAT]) 39 results CINAHL search September 16, 2010 S1 (MH "Acute Disease") Limiters - Exclude MEDLINE records Search modes -Boolean/Phrase S2 (MH "Emergency MedicalServices") OR (MH "Emergency Service") OR (MH "Emergency Nursing") OR (MH "Emergency Medicine") Limiters - Exclude MEDLINE records Search modes - Boolean/Phrase S3 (MH "Asthma") Limiters - Exclude MEDLINE records Search modes - Boolean/Phrase S4 heliox OR zileuton OR zarfirlukast OR methylxanthines Search modes - Boolean/Phrase S5 (MH "Disease Exacerbation") Search modes - Boolean/Phrase S6 (MH "Magnesium Sulfate") OR (MH "Continuous Positive Airway Pressure") OR (MH "Epinephrine") OR (MH "Terbutaline") OR (MH "Leukotriene Antagonists") OR (MH "Montelukast") OR (MH "Phosphodiesterase Inhibitors") Limiters - Exclude MEDLINE records Search modes - Boolean/Phrase S7 S1 or S2 or S5 Search modes - Boolean/Phrase S8 S3 and S7 Search modes - Boolean/Phrase S9 S4 or S6 Search modes - Boolean/Phrase S10 S8 and S9 Search modes - Boolean/Phrase S11 S8 and S9 Limiters - Published Date from: ; English Language; Human; Publication Type: Algorithm, Clinical Trial, Journal Article, Nursing Interventions, Practice Guidelines, Protocol, Systematic Review; Age Groups: All Child Search modes - Boolean/Phrase S12 S8 and S9 Limiters - Published Date from: ; English Language; Age Groups: All Child Search modes - Boolean/Phrase 0 results 23