Management of Asthma in Children Below Five Years of Age - Essay Example

ANALYSIS OF WHETHER IN ASTHMATIC CHILDREN UNDER THE AGE OF 5YRS SPACER INHALER IS MORE BENEFICIAL THAN A NEBULIZER Presented to [Teacher’s InPartial Fulfillment of the Requirements of [Project/Course name] Dated: In Asthmatic Children under the age of 5yrs is spacer inhaler more beneficial than a nebulizer? Objective of the review The objective of this review is to analyze whether spacer inhaler is more beneficial than a nebuliser for asthmatic children who are below the age of 5 years. While nebulisers have an historic record as having been used in acute asthma exacerbations , meta- analysis of trials with children below 5 years with chronic a pulmonary disease suggest that spacer inhalers are effective(Dolovich, 2010). The clinical question is: “in asthmatic children under the age of 5 years is spacer inhaler more beneficial as compared to the nebulizer.” Relevance Spacer inhaler has become the most preferred modality for delivering preventer and curative therapy in children below five years with asthma. The recent British thoracic Society Guidelines (20) support the use of spacer inhaler over the nebulizer. The possible advantages that accrue include reduced cost of acquisition and operation, greater potential convenience and reduced incidence of infection. It is therefore very important to asses whether spacer inhalers are beneficial in children with with extremely asthmatic episodes. The above clinical question and the suggested intervention measures are relevant in clinical practice of our modern society. PICO Summary P- Patient problem or population: asthmatic children below the age of 5 years I- Intervention interest: promote the use of spacer inhalers depending on the available modalities of convenience. C- Comparison interest: indicate that nebuliser too can offer convenience depending on the prevailing situational circumstance in relation to time, cost and available staff training and level of professionalism. O- Outcome interest: use of the spacer inhaler or the nebuliser offer substantive services depending on the convenience however spacer inhalers are quite effective. Search for the articles relevant for this research review was computer based. Article database search was based on the PubMed directory. An updated PubMed search (8 April 2013), with the key terms “asthma” “ spacer”, “nebuliser verses spacer inhaler”, “asthma spacer inhaler”, “spacer nebuliser comparison”, “acute asthmatic children”, “or asthma with the key term limit of meta analysis, human, all children 0-5 years. This led to acquisition of 15 citations which included two systematic reviews. First search was done based in the key terms that reflect the clinical problem “asthmatic children, nebuliser verses spacer inhaler”, “acute asthmatic” and “asthma”. This directed the search towards the acquisition of many other incidences which are prevalent to the problem in question. By reading the abstracts and key terms of the first acquired article, other terms like “juvenile asthma” and “asthma spacer nebulizer”. This gave out a new dimension of the review. The new article obtained from the secondary search show a considerable compliance and correlation of the primary sources. They both had a lot of randomized trials, testing the benefits of the use of spacer inhaler over the nebuliser while others indicate the overwhelming benefits of both. Most of the sources found were from: 1. Cumulative Index to Nursing and Allied Health Literature (CINAHL), EBSCO, MEDLINE. 2. Science direct data base. 3. EBSCOhost: Academic MEDLINE, CINAHL; 4. On line scientific Google. The search finding was quite substansive in regard to the clinical problem in question that is the beneficial implication of the spacer inhaler over the nebuliser and asthmatic child below the age of five years. The total number of articles obtained were twenty five but about fifteen of then were excluded as they centered their objectives on the “importance of spacer inhaler over the nebuliser on the adults” while others based their interest on the unsuitability of the spacer inhaler on children above the age more than twelve years. Data analysis plan Assessment of risk of bias of included studies The author ascertained the credibility of the methodological quality of the trials that were included with specific emphasis put on the allocation concealment. This was ranked using Cochrane approach: Grade A: Adequate concealment Grade B: Uncertain C: Clearly inadequate. The results for children below the age of 5 years were separate from those of above this age of 5 years in their outcome in view of the significant heterogeneity identified in the pooled analysis. It can also be argued that children at this age baseline differ in their ability to use the devise, sensitivity and their degree to the side airway from inhaled antagonists(Burges, 2011) . This kind of scoring instrument report the blinded, randomization of dropouts and withdrawals. Sensitivity analysis Based on methodology quality , The author performed sensitivity analysis. The results collected from the studies were re-analyses using hog quality studies only. Sensitivity analysis can also be performed to ascertain the impact of estimating the standard deviations and any data re analyzed without estimated results. The author also performed a funnel plot of admissions in hospital to check bias in publications. Discussion Methodological limitation Generalisability of the results of this review is restricted by several issues 1. Few authors indicate the specific number of patients excluded from their studies. There was no report on the intention to treat the analysis. It therefore shows it lacks clarity on how the results are applied to all patients who are in their exacerbations. 2. Since patients with a cute asthma were excluded from the studies, the results cannot be applied to this group of patients who were not considered the case wt ventilation problems of asthma. 3. Only two small studies were carried out in a community set up(Lazarus, 2010) 4. most of the papers lacked standardized reporting thus data analysis regarding lung function not considered for ventilation. Clinical practice Nebulisers are mostly utilized to deliver treatment in acute asthma in hospital emergency department and in the community setting. Even though space inhalers have been promoted and reported to be used in this circumstances, few details of published guidelines provide few procedures of use. Several of this reviews advocate the equivalence of nebuliser and spacer administration, in the acute asthma treatment. The review indicates that the pediatric patients treated by spacers have a shorter stay in the emergency department and reduce rate of pulse as compared to nebuliser treated patients. Of all the outcomes, no results were worse with spacer treatment. All the studies in this review excluded patients with life threatening asthma and in particular the patients who were considered for ventilation. It is therefore clear that the results of this review should not be applied or extrapolated to this group. As per the previous meta analysis, steroids reduce relapses when it is administered to patients after discharge and reduced possibility of hospitalization in case they are used in the course of earlier emergency treatment(Goh, 2011). Considerations of costs may dictate which delivery systems is best for different setting. In most parts of the world nebulisation is not available in clinics and peripheral hospitals for economic reasons(Schultz, 2011). Most recent studies include costs of drug treatment in their calculation(Burges, 2011, Doan, 2011 & Lazarus, 2010 ). Total costs in a hospital setting are more complex to calculate;burgers but when patients return to the community the cost of a home care nebuliser and respules is considerably more than spacer and MDI (and the nebuliser requires regular maintenance). A recent before-after ED study (Yilmaz, 2009) assessed the consequences of changing the acute asthma treatment algorithm from nebulised to MDI/spacer albuterol (salbutamol). TABULAR SUMMARY OF THE STUDIES Yilmaz, 2009 Method Randomization: Just described as randomized Blinding: none. Excluded: three out of 153 patients Withdrawals: none Baseline characteristics: significantly higher PEF at baseline in spacer group Participants Setting: Emergency Room in the National Institute of Child Health in Karachi between the dates of October 2005 to March 2008 150 children (aged 6 months to 15 years). 76% were classified as having as severe asthma attack while 24% had mild or moderate) Inclusion criteria: acute asthma Exclusion criteria: children who required intensive care management, under 90 % oxygen saturation in room air PEFR values under 20% or over 70% predicted,, or receiving daily systemic corticosteroids for not less than two weeks before being visited in the emergency room Intervention Beta2-agonist: Salbutamol (Albuterol) Spacer: Babyhaler for younger children and spacer with mouthpiece for older children. Dosage: 2x100 mcg repeated three times at 20 minute intervals Nebuliser: Type 2 Fleam Nuova S.P.A., Bresia, Italy. Dosage: 0.3 mg/kg with 2ml Normal Saline repeated three times at 20 minute intervals Dosage ratio: unknown. Co-interventions: none reported. Outcome Admission to hospital. Pulse, Respiratory Rate, BP, Dyspnoea, Cyanosis, wheeze, PEFR, clinical score, measured at 10 mins, 20 mins and 2 hours after completion of treatment Notes No details are given for mean age in each group or how many children were able to perform PEFR. Trial included as mean age is almost certainly over 2 years old Risk Bias Item Authors judgment Description Adequate sequence generation Unclear No detail Allocation concealment No No detail Blinding hospital admission No Open study Kaashmiri(2010) Method A randomized, double-blind, parallel group, multi center study of albuterol HFA 180 μg (n = 43) or 360 μg (n = 44) via an MDI with a valved holding chamber and face mask in an urgent-care setting. Assessments: included adverse events, signs of adrenergic stimulation, electrocardiograms, and blood glucose and potassium levels. Efficacy parameters :included additional albuterol use and Modified Tal Asthma Symptoms Score ([MTASS] reduction in MTASS representing improvement). Participants Southampton General Hospital. children aged 1-6 years admitted to hospital with moderate or severe asthma. Inclusion criteria: moderate or severe asthma according to BTS criteria. Exclusion criteria: details awaited Intervention Beta2-agonist: details awaited Spacer: details awaited Nebuliser: details awaited Co-interventions: details awaited Outcome Duration of admission to hospital, oxygen saturation, increase in heart rate, increase in respiratory rate, drug costs Notes No SD data provided in abstract. Risk Bias Item Authors judgment Description Adequate sequence generation Unclear Described as randomized; other information not available Allocation concealment Unclear No details available Blinding hospital admission Unclear No details available Goh, 2011 Method Setting: KK womens and children’s hospital(Singapore) Randomization: allocated treatment to all patients who presented with asthma exacerbation. Excluded: non was excluded from the study. Withdrawal:no withdrawals Blinding: assessors blinded. Excluded: no details of how many patients were excluded. Withdrawals: none. Baseline characteristics: characteristics were comparable including proportions of emergency room attendance to average length of inpatient stay, cost of inpatient care and high dependency on intensive care. Intention to treat analysis: not described. Power calculation based on 15L/min difference in PEF. Participants Setting: KK womens and childrens hospital Singapore. 19 951 children aged below to 18 years. All patients were registered and their diagnosis details captured into the hospital database. An outcome and variance form for all admissions were filled up to track pathway compliance. Mean PEF at presentation: Spacer 174 L/min, Nebuliser 173 L/min. All patients with mild , moderate and severe exacerbation received salbutamol via MDI with spacer anti choline ipropium was also administered with spacer to reduce the need for admissions. Patients for whom respiratory arrest was prominent respiratory arrest received salbutamol and / or ipratropium bromide via nebulisers. Inclusion criteria: two or more previous acute exacerbations, mild to moderate current attack (PEF 50% to 79% of predicted). Intervention Beta2-agonist: Salbutamol. Spacer: 500 ml plastic mineral water bottle coated with detergent Dosage: Five separate 100 mcg actuations inhaled by tidal breathing for 20 seconds. Nebuliser: Nevoni (Sao Paulo, Brazil). Driving gas oxygen at 6L/min Dosage: 0.15 mg/kg salbutamol given up to maximum of 5mg Each group had repeated Treatment up to 3 doses. Dosage Ratio: 1 to 4 -10 (Spacer to Nebuliser) Co-interventions: Not specified. Outcome PEF, Pulse Oximetry, Heart Rate, Respiratory Rate, Clinical Score, Duration in Emergency Room Notes Upon discharge from hospitalization patients were given a written asthma action plan. This was meant to remind and empower them to manage mild expectations. Risk Bias Item Authors judgment Description Adequate sequence generation clear Described as not randomized; other information not available Allocation concealment Unclear Details not available Blinding hospital admission No Open label, only assessors were blinded Doan, 2011 Method Randomization: method not stated. Blinding: none recorded Excluded: not stated. Withdrawals: not stated. Baseline characteristics: not stated Participants Setting: Alexandria, Egypt. Outpatient department study of children presenting with acute asthma of moderate severity. 60 children aged 2 to 12 years. Inclusion criteria: no details. Exclusion criteria: no details. Intervention Beta2-agonist: Salbutamol. Spacer: ’Large volume’, up to 10 puffs of salbutamol given as single dose. Nebuliser: No details of nebuliser type, 0.15mg/kg salbutamol given up to maximum of 5mg. Driving gas not specified. Co-interventions: Not specified. Outcome Admission to hospital, change in symptom score, pulmonary function, oxygen saturation, increase in heart rate. 4 admissions in nebuliser group and 3 in holding chamber group. Symptoms, oxygen saturation and lung function reported as similar in both groups, and mean heart rate higher in the nebuliser group Notes Risk Bias Item Authors judgment Description Adequate sequence generation Unclear Described as randomized; other information not available Allocation concealment Unclear No available information Blinding hospital admission No Not blinded record Dolovich(2010) Method Randomization: pharmacy generated and blinded treatment packets supplied. Blinding: double-blind, double dummy. Excluded: number not stated. Withdrawals: 1 from each group refused both treatments and was admitted. 1 from nebulizer group refused the nebulizer but was treated with spacer and discharged. (All 3 were included in the analysis). Baseline characteristics: comparable for asthma severity. Intention to treat: performed. Power calculation: powered to detect a difference of 1.25 in clinical score between groups. Dolovich score: 5. Participants Beta2-agonist: Albuterol (Salbutamol). Spacer: Aerochamber. Dosage: 6x100mcg puffs inhaled separately by tidal breathing. Repeated every 20 minutes for a maximum of 6 treatments. Nebuliser: Marquest bowl with Hudson face mask. Dosage: 2.5mg every 20 mins for a maximum of 6 treatments, driven by wall oxygen. Double dummy methodology so placebo given by the other route to all children. Co-interventions: supplemental oxygen if SaO2 less than 92% and oral prednisone unless child had received oral steroids in past 24 hours. Dosage ratio: Spacer/Nebuliser = 1/4 Intervention Beta2-agonist: Albuterol (Salbutamol). Spacer: Aerochamber. Dosage: 6x100mcg puffs inhaled separately by tidal breathing. Repeated every 20 minutes for a maximum of 6 treatments. Nebuliser: Marquest bowl with Hudson face mask. Dosage: 2.5mg every 20 mins for a maximum of 6 treatments, driven by wall oxygen. Double dummy methodology so placebo given by the other route to all children. Co-interventions: supplemental oxygen if SaO2 less than 92% and oral prednisone unless child had received oral steroids in past 24 hours. Dosage ratio: Spacer/Nebuliser = 1/4 Outcome Admission to hospital. Pulse, Respiratory Rate, SaO2, clinical score, tremor and hyperactivity measured 20 mins after each treatment and 60 mins after final treatment Notes Data in the paper is only provided for the results 20 mins after the first treatment. One of the tables of data in the paper was inconsistent and has since been corrected. The data used preparedness in the review for heart rate and respiratory rate has been provided by Dr Dolovich Risk Bias Item Authors judgment Description Adequate sequence generation Unclear Described as randomized; no other information available Allocation concealment Yes Pharmacy generated Blinding hospital admission Yes Double dummy Schultz, 2011 Method Randomization: allocated using a numbered envelopes. Blinded: none excluded: 106 of the 185 children withdrawal: none from the initial study. Six families were lost due to longer term follow up. Baseline characteristics: both were comparable. Participants Setting: pediatric emergency department of France. 79 children who were aged between 4 to 15 years of the total 40 were allocated nebuliser 39 were allocated a spacer treatment. Inclusion criteria: based on severe acute exacerbation of asthma. The definition of severe asthma was understood as a non responsive to beta agonist therapy, an acute asthma attack which develops for more than twenty four hours or which recurs over one month of oral treatment of steroid or occurring after maintenance inhaled steroid treatment and an attack on a child who has ever had a previous intensive treatment for acute asthma Outcome Respiratory rate, pulse rate, hospitalization, SaO2, PEF Notes There was noted an imbalance baseline respiratory rate. This may have contributed to notable large fall in the nebuliser group Risk Bias Item Authors judgment Description Adequate sequence generation unclear No details given Allocation concealment yes Numbered envelops Blinding hospital admission no open Hassan (2009) Method Prospective, randomized, double blinded, placebo controlled trial in the emergency department (ED) in 60 acute asthma patients. Subjects were randomized to receive albuterol with MDI/spacer combination or nebulizer. The spacer group (N=29) received albuterol by MDI using LiteAire followed by placebo nebulization. The nebulizer group (N=29) received placebo by MDI using LiteAire followed by albuterol nebulization. Peak flows, symptom scores and need for rescue bronchodilator were monitored. Participants Setting ; not mentioned anywhere in the article 60 children aged 6 to 18 years old. 30 of these were included in this review (10 in each arm as detailed below). Both groups were followed for their expiratory peak flow, symptom severity and the number of rescue bronchodilator treatments every hour for a maximum of 6 hours. The triage decision to admit or discharge a patient from the ED was made within 6 hours of enrollment into the study and the study was terminated once the patient was discharged home, or admitted to the hospital. Patients were discharged or admitted based on NAEPP guidelines. Intervention Beta2-agonist: Salbutamol (Albuterol). Spacer A: Aerochamber, 4 x 100 mcg separate actuations of salbutamol given at 30 second intervals, inhaled using single deep breath per actuation. This was given three times at 20 minute intervals. Home made Spacer: 500 ml plastic water bottle, 4 x 100 mcg separate actuations of salbutamol given at 30 second intervals, inhaled using single deep breath per actuation. This was given three times at 20 minute intervals. Nebuliser: Paris Jet, 0.15 mg/kg salbutamol given every 20 minutes in 3 ml saline driven by Proned ultra compressor (air driven). Dosage ratio: Spacer/Nebuliser = 1/12.5. Co-interventions: not specified. (The further 10 children treated with dry powder inhaler were not included in this review) Outcome Admission to hospital, duration in emergency department, change in symptom score, final Peak Flow (in children old enough to perform test), oxygen saturation, increase in heart rate, administration of steroids Notes Standard deviation of results and details of randomization obtained from author; SD of change in lung function estimated Risk Bias Item Authors judgment Description Adequate sequence generation Yes Random numbers table Allocation concealment Yes Sealed opaque envelops Blinding hospital admission No open Implication of changes in practice Implementation of the research finding on this study is not an easy process. Powell(2007) found that structural strategies were require to change hospital practice from nebuliser to spacer inhaler. As earlier stated, the cost of implementation becomes a challenge in the implementation of the new less costly strategy. Among the challenges found were the perceived costs and safety implications and lack of willing physicians to champion for the anticipated change. Conclusion Implication for practice 1. In children within the age bracket of study there were no significant worse out come with the use of spacer. Most of the studies avail an evidence that suggest that spacer formed the best substitutes to deliver treatment for Listerine acute asthmatic cases 2. In Many studies the experimental methods adopted was given repeated treatment at short time intervals. A good example is the administration of one respule through a nebuliser or administration of 4 actuations of a metered dose through a spacer inhaler for every 10 to 15 minutes. Based on individual patient response, most treatment were adjusted to overcome the ascertained of delivering dosages by the use of different devises. This method which can be adjusted to meet the individual needs remains outstanding until another evidence is made available. 3. Since the study exclude patients who are at the critical stage of asthma, need not be extrapolated to this finding. Implication of the research 1. More research studies are needed to confirm whether this hospital findings based on emergency department can be extrapolated in the setting. 2. It needs further strategic plans to implement a change that can improve or eliminate the nebuliser culture. 3. Further studies in asthmatic children with severe asthma cases need be employed to ascertain whether spacers are as beneficial as nebuliser in this group. 4. Future studies should employ multiple treatment based on individual patients at short intervals in order to avoid confounding the close of the drug that delivered to the airways. References British Thoracic Society. British Guidelines on Asthma Management(2008). Thorax; 58 (Suppl 1): i1-i94. Burgess, S., Sly, P., & Devadason, S. (2011). Adherence with preventive medication in childhood asthma. Pulmonary Medicine, 2011. Doan, Q., Shefrin, A., & Johnson, D. (2011). Cost-effectiveness of metered-dose inhalers for asthma exacerbations in the pediatric emergency department. Pediatrics, 127(5), e1105-e1111. Dolovich MB, Dhand R(2010). Aerosol drug delivery: developments in device design and clinical use. Lancet. 2011;377(9770):1032–45. Epub . Kaashmiri M, Shepard J, Goodman B, Lincourt WR, Trivedi R, Ellsworth A, Davis AM(2010). Repeat dosing of albuterol via metered-dose inhaler in infants with acute obstructive airway disease: a randomized controlled safety trial. Pediatr Emerg Care ;26(3):197-202. Goh, A. E. N., Tang, J. P. L., Ling, H., Hoe, T. O., Chong, N. K., Moh, C. O., & Huak, C. Y. (2011). Efficacy of metered‐dose inhalers for children with acute asthma exacerbations. Pediatric pulmonology, 46(5), 421-427. Hassan, H. E. (2009). Randomized control trial of albuterol therapy comparing MDIs with spacer vs. nebulizers for treatment of acute wheezing in children aged 2 years and younger in the ED setting. Lazarus, S. C. (2010). Emergency treatment of asthma. New England Journal of Medicine, 363(8), 755-764. Powell CV, Maskell GR, Marks MK, South M, Robertson CF(2007). Successful implementation of spacer treatment guideline for acute asthma. Archives of Disease in Childhood ;84: 142–6. Schultz A, Le Souëf TJ, Venter A, Zhang G, Devadason SG, Le Souëf PN(2011). Aerosol inhalation from spacers and valved holding chambers requires few tidal breaths for children. Pediatrics. 2010;126(6):e1493–8. Epub Read More