Albuterol & Bronchiolitis

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Gadomski, AM et al. "Efficacy of Albuterol in the Management of Bronchiolitis". Pediatrics. 1994. 99(6):907-912.
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Clinical Question

In infants presenting for their first episode of wheezing, is the use of albuterol more effective than placebo in reducing symptoms of bronchiolitis?

Bottom Line

Albuterol is no more effective than oral placebo in the management of bronchiolitis in infants.

Major Points

Bronchiolitis is a common pediatric disease with controversial management guidelines. Previous studies assessing the use of beta-agonists have been small and poorly designed. Beta-agonists have also been linked to adverse outcomes when used in the management of bronchiolitis.

This trial by Gadomski et al randomized 88 infants in a blinded fashion to nebulized albuterol, nebulized saline, oral albuterol, or oral placebo. There were no differences in the primary outcomes of change in oxygen saturation, respiratory rate, or clinical severity score. The oral albuterol group experienced an increase in heart rate. As such...

Guidelines

The 2006 AAP guidelines on bronchiolitis.[1]

Design

  • Randomized, double-blind, placebo controlled trial
  • N=88
    • Nebulized albuterol (n=22)
    • Nebulized saline (n=23)
    • Oral albuterol (n=19)
    • Oral placebo (n=24)
  • Setting: Pediatric ER and outpatient clinic at University of Maryland
  • Enrollment: 1990-1992
  • Analysis: Intention-to-treat
  • Primary outcomes:
    • Respiratory and heart rates
    • Clinical Score
    • Oxygen saturation
    • Infant’s state (asleep, awake, feeding)

Population

Inclusion Criteria

  • Infants between 0 and 15 months presenting with first episode of wheezing to pediatric ER or outpatient clinic
  • Bronchiolitis defined as:
    • Acute infection of lower respiratory tract
    • Preceded by or accompanied by fever +/- rhinitis
    • Tachypnea, expiratory wheezing, and increased work of breathing on exam

Exclusion Criteria

  • Previous bronchodilator use
  • History of intubation or mechanical ventilation
  • Chronic cardiorespiratory disease
  • Severely ill infants as defined by:
    • HR >200
    • RR >100
    • Lethargy
    • Concern for impending respiratory failure or sepsis

Baseline Characteristics

From the nebulized albuterol group.

  • Demographics: Age 22 months, male 45%, black race 91%
  • Presentation: Wheezing duration 2.4 days, asleep 27%, RR 59 breaths/min, score 9, SpO2 97%, HR 150 BPM
  • Health data: Birth weight 2,889 g
  • RSV positive culture: 55%
  • Smoker in home: 86%, 1.1 ppd on average
  • Family history: Asthma 35%

Interventions

  • Patients were randomized to:
    • Nebulized albuterol 0.15mg/kg per dose for two treatments, 30 minutes apart
    • Nebulized saline for two treatments, 30 minutes apart
    • Oral albuterol 0.15mg/kg per dose for one treatment at 30 minutes
    • Oral placebo (oral rehydration solution) for one treatment at 30 minutes
  • Respiratory status was re-evaluated at 30 and 60 minutes. If status worsened or failed to improve after 60 minutes, an additional nebulized albuterol treatment was given.

Outcomes

Comparisons are nebulized albuterol vs. nebulized saline vs. oral albuterol vs. oral placebo.

Primary Outcomes

Change in respiratory rate
30 minutes: -11 vs. -5 vs. -3 vs. -9 breaths/min (NS)
60 minutes: -11 vs. -6 vs. -7 vs. -12 breaths/min (NS)
Change in heart rate
30 minutes: -2 vs. -6 vs. +8 vs. -6 BPM (NS)
60 minutes: +2 vs. -4 vs. +15* vs. -5 BPM (NS except *F=4.2; df=3; P=0.008)
Change in clinical score*
A severity of illness score was developed with 9 signs of illness each ranging from 0 (none) to 3 (most severe) with maximum total score of 27.
30 minutes: -2 vs. -4 vs. -5 vs. -2 (NS)
60 minutes: -5 vs. -4 vs. -6 vs. -3 (NS)
Oxygen saturation
30 minutes: -0.2 vs. -0.3 vs. +1.1 VS. -0.1% (NS)
60 minutes: +0.1 vs. +0.1 vs. +1.0 vs. +0.1% (NS)
Infant's state
Asleep: Ranging 27-48% (NS)
Waking up at 60 min: Ranging 35-44% (NS)
No change in state at 60 min: Ranging 32-55% (NS)

Secondary Outcomes

Requiring additional nebulization
32% vs. 35% vs. 26% vs. 50% (NS)
Requiring hospitalization
14% vs. 9% vs. 10% vs. 17% (NS)

Adverse Events

Facial flushing
16% vs. 0% vs. 6% vs. 0% (no statistics given)
Hyperactivity
10% vs. 0% vs. 6% vs. 0% (no statistics given)
Increased coughing
0% vs. 4% vs. 0% vs. 4% (no statistics given)
Tremor

0% vs. 0% vs. 5% vs. 4%

Criticisms

  • Narrow age range
  • Groups that changed state (asleep to awake) were too small to apply statistical analyses

Funding

  • Glaxco, Inc
  • Nellcor, Inc provided a pulse oximeter

Further Reading

  1. 2006 AAP Bronchiolitis Guidelines