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Multicenter randomized clinical trial comparing dexamethasone versus placebo in preventing upper airway obstruction
Laura Butragueño-Laiseca1,2,3, Gema Manrique Martín1,2,3, Rafael González Cortés4,5,6,7
1Service of Pediatric Intensive Care, Gregorio Marañón General University Hospital, Calle Doctor Castelo 47, 28009, Madrid, Spain.
Insights
Dexamethasone did not significantly reduce upper airway obstruction (UAO) symptoms in critically ill children post-extubation, but it lowered the Taussig score and reduced reintubation needs in those intubated longer than 5 days.
Area of Science:
- Pediatric Critical Care Medicine
- Pharmacology
- Respiratory Medicine
Background:
- Upper airway obstruction (UAO) is a significant concern in critically ill children after extubation.
- Preventing UAO symptoms and reintubation is crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of dexamethasone in preventing UAO symptoms and reducing reintubation rates in pediatric patients post-extubation.
- To analyze the impact of dexamethasone on symptom severity scores and the need for rescue therapies.
Main Methods:
- A multicenter, prospective, double-blind, randomized, phase IV clinical trial was conducted.
- 147 children (1 month to 16 years) intubated >48 hours received either placebo or dexamethasone (0.25 mg/kg every 6 hours for four doses) prior to extubation.
- Follow-up included assessment of UAO symptoms (Taussig score, stridor) and reintubation requirements within 48 hours.
Main Results:
- No significant global difference in stridor or moderate-to-severe UAO symptoms (Taussig ≥5) was observed.
- Dexamethasone significantly reduced the median Taussig score 1 hour post-extubation (p < 0.001) and UAO symptoms in patients under 2 years (p=0.014).
- Reintubation due to UAO was less frequent in the dexamethasone group (4.3% vs. 8.9%), particularly in patients intubated >5 days (p=0.052). Rescue therapies like nebulized epinephrine and budesonide were used less in the dexamethasone group.
Conclusions:
- Dexamethasone did not significantly reduce overall moderate-to-severe UAO symptoms but showed benefit in younger children (<2 years).
- The study suggests dexamethasone may decrease symptom severity, reduce the need for rescue therapies, and lower reintubation rates in prolonged intubation cases (>5 days).
- No significant adverse effects were noted, indicating a favorable safety profile for peri-extubation dexamethasone use in this population.
Abstract:
To analyze the effectiveness of dexamethasone in preventing upper airway obstruction (UAO) symptoms after extubation and the need of reintubation in critically ill children. Multicenter, prospective, double-blind, randomized, phase IV clinical trial involving five pediatric intensive care units. Children between 1 month and 16 years-of-age intubated for more than 48 h were included. Patients were randomized to receive placebo or dexamethasone 0.25 mg/kg every 6 h, 6-to-12 h prior to extubation (four doses). 48 h follow-up was carried out after extubation. Severity of UAO symptoms (Taussig score, stridor) and reintubation requirement were compared. 147 patients were randomized (10 were excluded), 70 patients received dexamethasone and 67 placebo. No global differences were found in the presence of stridor or moderate-to-severe UAO symptoms (Taussig ≥ 5), but Taussig ≥ 5 was less frequent in patients less than 2 years-of-age treated with steroids (p = 0.014). Median Taussig score was lower in the dexamethasone group 1 h after extubation, p < 0.001. 27 patients required reintubation, 9 due to UAO: 3 (4.3%) in the dexamethasone group and 6 (8.9%) in the placebo group, p = 0.319. In those intubated > 5 days, reintubation due to UAO was higher in the placebo group (2.4% vs. 14.3, p = 0.052). Nebulized epinephrine and budesonide were required more frequently in the placebo group in the first 2 h (p = 0.041) and 1 h (p = 0.02) after extubation, respectively. No relevant side effects were observed. Dexamethasone prior to extubation did not significantly reduce moderate-severe UAO symptoms, except for patients under 2-years of age. Dexamethasone could decrease Taussig score and the need of rescue therapies, as well as reintubation rates in those intubated for more than 5 days.
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