Elsevier

The Journal of Pediatrics

Volume 141, Issue 6, December 2002, Pages 818-824
The Journal of Pediatrics

Original Articles
A randomized, controlled trial of the effectiveness of nebulized therapy with epinephrine compared with albuterol and saline in infants hospitalized for acute viral bronchiolitis*,**

https://doi.org/10.1067/mpd.2002.129844Get rights and content

Abstract

Objective: In previously well infants hospitalized with acute viral bronchiolitis, the effectiveness of repeated nebulized therapy with epinephrine (EPI) was compared with treatment with albuterol (ALB) or saline placebo (PLAC). Study design: In this randomized, double-blind, parallel-group, controlled trial, infants received study nebulizations every 1 to 6 hours and were assessed twice daily by the research team. The primary outcome was length of hospital stay (LOS). Secondary outcomes included the time from admission until the infant had normal hydration, oxygenation, and minimal respiratory distress. Results: A total of 149 infants were randomized; 50 were allocated to receive racemic EPI, 51 were given ALB, and 48 received PLAC. Baseline characteristics and pre-enrollment symptoms, signs, and therapy were similar between groups. There were no group differences in the primary outcome measure, mean LOS (hours)(± SD): EPI = 59.8 (62), ALB = 61.4 (54), and PLAC = 63.3 (47); P =.95 by intent-to-treat analysis. Group differences were not statistically significant in any of the secondary outcomes. Conclusions: There were no group differences in the effectiveness of therapy for infants hospitalized with bronchiolitis. Based on these results, we do not recommend routine use of either nebulized EPI or ALB in this patient group. (J Pediatr 2002;141:818-24)

Section snippets

Study design

This study was a double-blind, randomized placebo-controlled, parallel-group trial, approved by the Scientific Review Committee of the Montreal Children's Hospital (MCH) Research Institute and by the MCH Institutional Review Board.

Study setting

Infants were recruited throughout two successive bronchiolitis winters (mid November to March; 1998-1999 and 1999-2000) at the time of hospital admission from the emergency department (ED).

Study participants

Eligible infants included all previously well infants (aged ≤12 months) with a

Results

During the study, 495 infants with bronchiolitis were hospitalized and 149 infants entered the study. Reasons for exclusions are detailed in Fig 1 along with patient allocation by treatment group.

. Flow diagram of patient allocation. *Reason for exclusion: previous wheezing (110), consent declined (43), missed recruitment (42), >12 months, (38), apneic spells/ICU admission (28), >8 hours of therapy pre-enrollment (26), gestational age <34 weeks (17), attending physician refused participation

Discussion

We found no clinically significant difference in the primary outcome measure, LOS, in infants treated with extended-use nebulized EPI compared with those who received either nebulized ALB or PLAC. This observation was supported by the lack of significant group differences in all secondary and follow-up outcomes including the time to normal oxygenation; adequate fluid intake; RDAI clinical score ≤4; infrequent nebulizations; and revisit and re-admission rates. Results from the primary

Acknowledgements

We thank Natalie Ross (administration) and Isabelle Morin (statistical analyses) for their invaluable help. We acknowledge the cooperation of the Emergency Department, the Department of Pharmacy (Patricia Vandercruys), the General Pediatric Ward Staff and especially the Bronchiolitis Research Team.

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    • Cited by (0)

    *

    Supported by the Medical Research Council of Canada (now the Canadian Institutes of Health Research).

    **

    Reprint requests: Hema Patel, MD, MSc, FRCPC, 2300 Tupper St, Room A-216, Montreal, Quebec, Canada H3H 1P3. Email: [email protected].

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