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24-hour Pretreatment with Low Dose (0.25mg/Kg/dose) versus High Dose (0.5mg/Kg/dose) Dexamethasone for prevention of Post-Extubation Airway Obstruction in Children: A Randomized Open-label Non-inferiority Trial
  • +2
  • Biraj Parajuli,
  • ARUN BARANWAL,
  • PRAVEEN KUMAR-M,
  • MURALIDHARAN JAYASHREE,
  • LALIT TAKIA
Biraj Parajuli
Chitwan Medical College
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ARUN BARANWAL
PGIMER
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PRAVEEN KUMAR-M
PGIMER
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MURALIDHARAN JAYASHREE
PGIMER
Author Profile
LALIT TAKIA
PGIMER
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Abstract

Objective: Multi-dose dexamethasone pretreatment prevents postextubation airway obstruction (PEAO), however, its optimal dose in children is not known. We planned to compare effect of 24h pretreatment of low dose (LD) (0.25mg/kg/dose) versus high dose (HD) (0.5mg/kg/dose) dexamethasone for prevention of PEAO. Design: Stratified (for age and intubation duration) randomized open-label non-inferiority trial. Setting: 15-bed Pediatric Intensive Care Unit in a tertiary care teaching hospital of a lower-middle income country. Patients: Children (3mo-12yrs) intubated for ≥48h and planned for first extubation over 26 months (Feb’17 to Mar’19). Children with preexisting upper airway conditions, chronic respiratory diseases, steroid or IVIG therapy in last 7 days, gastrointestinal bleeding, hypertension and hyperglycemia were excluded. Interventions: Low dose (n=144) or high dose (n=143) dexamethasone (q6h) for 6 doses. Extubation was planned after 5th dose. Measurements and Main Results: Patients were monitored for PEAO (Westley’s Croup Score >4) for 24 hours. 238 patients were included in per-protocol analysis. 78 patients (33%) developed PEAO; both groups were similar (LD, 41/121, 34% vs HD, 37/117, 32% p=0.71). Risk difference of LD vs HD touches the non-inferiority margin of 0.12 and hence the overall result is non-significant. Incidence of reintubation was also similar (LD, 10/121, 8.3% vs HD, 9/117, 7.7%; p=0.87). Intubation for more than 7 days was an independent risk factor for development of PEAO. Conclusions: Multi-dose 24-hour pretreatment with low dose dexamethasone is not inferior to high dose in preventing PEAO and reintubation among unselected patients in the studied clinical setting. Multi-centric trials with larger sample size among children at high risk of developing PEAO are needed.

Peer review status:ACCEPTED

09 Jun 2020Submitted to Pediatric Pulmonology
09 Jun 2020Submission Checks Completed
09 Jun 2020Assigned to Editor
01 Jul 2020Reviewer(s) Assigned
07 Aug 2020Review(s) Completed, Editorial Evaluation Pending
16 Oct 2020Editorial Decision: Revise Major
20 Dec 20201st Revision Received
29 Dec 2020Submission Checks Completed
29 Dec 2020Assigned to Editor
29 Dec 2020Reviewer(s) Assigned
17 Jan 2021Review(s) Completed, Editorial Evaluation Pending
24 Jan 2021Editorial Decision: Revise Minor
04 Feb 20212nd Revision Received
05 Feb 2021Submission Checks Completed
05 Feb 2021Assigned to Editor
05 Feb 2021Reviewer(s) Assigned
19 Feb 2021Review(s) Completed, Editorial Evaluation Pending
01 Mar 2021Editorial Decision: Revise Minor
08 Mar 20213rd Revision Received
08 Mar 2021Submission Checks Completed
08 Mar 2021Assigned to Editor
08 Mar 2021Reviewer(s) Assigned
08 Mar 2021Review(s) Completed, Editorial Evaluation Pending
11 Mar 2021Editorial Decision: Accept