Does nebulized epinephrine improve the efficacy of hypertonic saline solution in the treatment of hospitalized moderate acute bronchiolitis? A double blind, randomized clinical trial.

BACKGROUND

Nebulized 3% hypertonic saline solution (HSS 3%) has proven to reduce hospital stay in infants with acute bronchiolitis, as compared with nebulized physiological saline solutions. There are no studies assessing the effectiveness of nebulized epinephrine in patients treated with HSS 3%. The aim of this study was to compare the length of stay (LOS) in hospitalized patients treated with HSS 3% with placebo vs. HSS 3% with epinephrine. Secondarily we aimed to assess the effectiveness and safety of both treatments.

METHODS

We performed a prospective, randomized, double-blind, parallel-group study, including infants hospitalized for moderate acute bronchiolitis. Both groups received standard life support and were randomly treated with nebulized HSS 3% (7 mL) with either placebo 3 mL or epinephrine 3 mL. Nebulizations were initially administered every four hours and this interval was modified according to the patient's response.

RESULTS

Sixty-four infants were included, 32 patients in each group. No statistically significant differences were found between the two groups (P=0.948) in length of stay, disease severity, SatO2, respiratory rate or heart rate. On the third day of hospitalization, severity and respiratory rate in the HSS 3%+E presented a non statistically significant trend to an earlier improvement, (P=0.063 and P=0.096 repectively). No adverse events occurred. Four patients (two from each group) required transfer to the pediatric intensive care unit.

CONCLUSIONS

With a third of the final estimated sample, we find a trend to an earlier clinical recovery in the epinephrine group, even though no statistical significant differences in LOS were found. The study needs to be continued until the total sample is recruited.