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Aminophylline therapy does not improve outcome and increases adverse effects in children hospitalized with acute
R E Strauss1, D L Wertheim, V R Bonagura
1Allergy and Immunology Division, Long Island Jewish Medical Center, New Hyde Park, NY.
Insights
Aminophylline (Am) offers no benefit for hospitalized asthmatic children and increases the risk of adverse effects like nausea and vomiting. This study found no significant differences in recovery between Am and placebo groups.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Asthma exacerbations are a common reason for pediatric hospitalization.
- Theophylline, including aminophylline (Am), has been used historically for asthma management.
- Evidence for Am's efficacy and safety in hospitalized pediatric asthma patients requires clarification.
Purpose of the Study:
- To investigate the clinical effects of aminophylline (Am) in children hospitalized with asthma exacerbations.
- To compare the outcomes of Am treatment versus placebo in this pediatric population.
Main Methods:
- A prospective, randomized, double-blind, placebo-controlled trial was conducted.
- Participants included children aged 5-18 years admitted for asthma exacerbation.
- Patients received standard albuterol and glucocorticosteroid therapy; treatment groups received either Am or placebo.
Main Results:
- No significant differences were observed in hospitalization duration, peak expiratory flow rates, or albuterol requirements between the Am and placebo groups.
- Patients receiving Am experienced significantly higher rates of adverse effects, including nausea, emesis, and headache, compared to the placebo group.
- The study included 26 patients who completed the trial, with 11 in the Am group and 15 in the placebo group.
Conclusions:
- Aminophylline (Am) does not provide clinical benefit for hospitalized asthmatic children.
- The use of Am in this population is associated with a considerable risk of adverse effects.
- Current evidence suggests avoiding Am for pediatric asthma hospitalizations due to lack of efficacy and safety concerns.
Objective:
To evaluate the effects of aminophylline (Am) in children hospitalized with asthma.
Methods:
Prospective, randomized, double-blind, placebo-controlled trial. Subjects were children between the ages of 5 and 18 years admitted for asthma exacerbation to either a tertiary care children's hospital or an inner-city general hospital in New York. Exclusion criteria were admission to the intensive care unit, initial theophylline level > 5 micrograms/dL, or the presence of other systemic disorders. All patients received nebulized albuterol therapy and intravenous glucocorticosteroids in standardized doses. Thirty-one patients were randomized to receive either an Am bolus followed by continuous Am infusion or placebo (P) bolus and infusion. The outcome variables were: duration of hospitalization, percent of predicted peak expiratory flow rates recorded at 12-hour intervals, number of albuterol treatments required, and adverse effects.
Results:
There were no significant differences at study entry in age, sex, race, number of previous hospital admissions, prior medications used, clinical symptom scores, or initial peak flow rates for the two groups. For 26 patients who completed this study, 15 patients in the P group were hospitalized for a mean duration of 2.33 +/- 1.3 days, whereas 11 patients in the Am group required 2.58 +/- 1.5 days. There were no significant differences between the two groups for hospital days, peak flow rates at any time interval, or amount of albuterol therapy required (P > .2). In the Am group, 6 of the 14 patients who entered the study experienced significant adverse effects consisting of nausea, emesis, headache, abdominal pain, and palpitations. Only 1 of 17 patients in the P group had an adverse effect (P < .05).
Conclusions:
There is no benefit and considerable risk of adverse effects associated with the use of Am in hospitalized asthmatic children.
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