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7% Hypertonic Saline In Acute Bronchiolitis: A Randomized, Controlled, Double-Blind Trial

Friday, October 19, 2012: 4:15 PM
Room 278-280 (Morial Convention Center)
Jonathan D. Jacobs, MD1, Megan Foster, Pharm, D, BCPS2, Jim Wan, PhD3 and Jay Pershad, MD2, (1)Pediatrics, Division of Emergency Medicine, University of Tennessee & Le Bonheur Children's Hospital, Memphis, TN, Memphis, TN, (2)Pediatrics, Division of Emergency Medicine, University of Tennessee & Le Bonheur Children's Hospital, Memphis, TN, (3)Biostatistics and Epidemiology, University of Tennessee, Memphis, TN

Purpose

Hypertonic saline (HS) is purported to improve mucous rheology in patients with acute bronchiolitis. Prior studies with HS for treatment of acute bronchiolitis in the emergency department (ED) suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with nebulized 3% and 5% saline as compared to 0.9% saline mixed with epinephrine. To our knowledge, 7% HS has not been previously investigated. 

Methods

We conducted a prospective, double-blinded, randomized, controlled trial at an urban, tertiary level, academic, pediatric center with an annual ED census of 72,000 patient visits. Infants 6 weeks -18 months of age presenting with moderate to severe acute bronchiolitis, as determined by a bronchiolitis severity score (BSS) ≥ 4, were eligible for enrollment.   Subjects were excluded if they were ≤ 34 weeks gestation, had wheezed before, required endotracheal intubation or had a prior history of cardiac, pulmonary, or renal disease.  Subjects were randomized to receive via a nebulized inhalation treatment, either the study drug (7% saline with epinephrine) or control (0.9% saline with epinephrine).  BSS was obtained before and after the initial treatment and again at the time of disposition from ED.  Patients that were admitted to the hospital, continued to receive the same medication they were randomized to, every 6 hours, for a total of 4 inpatient doses. A BSS was recorded before and after each treatment.  Co-interventions and final disposition was determined at the discretion of the treating clinician.  Our primary outcome was a change in BSS at the time of disposition from ED.  Secondary outcomes measured were; hospitalization rate, proportion of admitted patients discharged at 23 hours, ED and inpatient length of stay.

Results

One hundred and one subjects were enrolled, 51 to HS and 49 to control group.  The two groups were similar with regards to age, gender, weight, duration of symptoms, tobacco smoke exposure, presenting BSS and co-interventions. The decrease in mean BSS from baseline until the completion of their ED stay in the HS and control group was 2.6 + 1.9 and 2.4 + 2.3 respectively [difference in means 0.21, 95% CI (-0.61, 1.03), p =0.61] .  The difference in proportion of admitted patients in the HS group 42% vs. 49% in control group was not statistically significant [odds ratio 0.76, 95% CI 0.35, 1.7]. Similarly there was no statistical difference in ED or inpatient length of stay and proportion of admitted patients discharged at 23 hours.

Conclusion

In moderate to severe acute bronchiolitis, 7% HS with epinephrine does not appear to confer any clinically significant benefit when compared with 0.9% saline with epinephrine inhalation.