Randomized pilot trial of ipratropium versus placebo in children with critical asthma

Abstract

Objective To test the effects of inhaled ipratropium on clinical outcomes of critical asthma in the first randomized trial of this adjunctive therapy in critically ill children. Design Pilot, placebo‐controlled, double‐blinded, and randomized‐controlled trial Patients Thirty children (15 per group) with critical asthma receiving high‐intensity albuterol per a standardized pathway utilizing objective assessments to wean patients to less frequent albuterol administration. Interventions Subjects were randomized to receive either nebulized ipratropium bromide (500 µg in 0.9% saline per dose) or an equivalent volume of nebulized 0.9% saline every 6 h until the patient was successfully weaned to albuterol doses every 2 h (“q2 albuterol”). Measurements and Main Results Demographics, initial clinical severity score, and asthma histories were similar between groups. There was no significant difference in the median duration of high‐intensity albuterol between the treatment group (17.5 [10.3–22.1] h) and placebo group (14.6 [12.7–24.5] days; p = .56). Similarly, there was no significant difference in pediatric intensive care unit length of stay (22.6 [21.1–33.6] vs. 21.4 [16.1–35.8] h; p = .74) or hospital length of stay (48.0 [41.8–59.8] vs. 47.3 [37.2–63.1] h; p = .67). In multivariate linear regression adjusting for identified confounders, treatment with ipratropium was not significantly associated with any of the three outcomes. Side effects were rare and occurred with equally between both groups Conclusions Adjunctive therapy with ipratropium was not associated with decreased duration of high‐intensity albuterol or shortened length of stay when compared to placebo. A larger, multicenter trial is warranted to confirm that ipratropium does not improve clinical outcomes.

Is Ipratropium Bromide useful in children with moderate Asthmatic Crisis? Experience of a Pediatric Emergency Department

“…Previous studies [16][17][18] concentrate on the impact of the addition of IB in hospital length of stay, proving that IB does not reduce days of hospital admission. However, there is no previous literature concerning its impact on the length of stay at the PED.…”

Pediatric Pulmonology 2020 year in review: Asthma

“…10 One single-center, double-blinded, randomized, controlled trial of 30 children requiring PICU admission for either continuous or hourly albuterol treatments addressed this question. 11 Investigators found no significant difference in duration of high-intensity albuterol, PICU length-of-stay, or hospital length-of-stay between those who continued to receive ipratropium bromide in the PICU and those who did not. This finding is consistent with previous studies analyzing ipratropium bromide given to asthmatic children hospitalized in the general ward.…”

“…The drug ipratropium bromide has been shown to decrease rates of hospitalization in children with asthma when given alongside systemic steroids and inhaled beta‐agonists in the emergency department, yet there have been no trials assessing the effect of ipratropium bromide use in critically ill asthmatics admitted to the pediatric intensive care unit (PICU) 10 . One single‐center, double‐blinded, randomized, controlled trial of 30 children requiring PICU admission for either continuous or hourly albuterol treatments addressed this question 11 . Investigators found no significant difference in duration of high‐intensity albuterol, PICU length‐of‐stay, or hospital length‐of‐stay between those who continued to receive ipratropium bromide in the PICU and those who did not.…”

Can less be more in critical asthma in children?

“…It is in this environment that a study such as Dr. Murphy's is impressively conducted 6 . Performing clinical trials of status asthmaticus in children at a single center requires a sustained effort over several asthma seasons.…”

“…In this issue of Pediatric Pulmonology , Murphy et al 6 conducted a randomized double‐blinded placebo‐controlled trial of ipratropium in children with critical asthma. Children were randomized to receive either ipratropium or placebo until they had been weaned to intermittent albuterol therapy every 2 h. This study, which stretched over 3 years, found no improvement in outcomes in the group that received ipratropium including similar hospital and PICU length of stay and similar time until spaced to every 2‐h albuterol.…”