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Dexmedetomidine vs Midazolam for Sedation in Mechanically Ventilated Children: A Randomized Controlled Trial

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Abstract

Background

There is a paucity of data on use of dexmedetomidine as a sedative agent in mechanically ventilated children.

Objectives

To compare the efficacy of dexmedetomidine and midazolam for sedation in mechanically ventilated children aged 1 month — 15 years. Secondary objectives were to compare the need for top-up doses of fentanyl and paralytic agents, duration of mechanical ventilation, ICU stay and hospital stay, and adverse events.

Design

Open label, non-inferiority, randomized controlled trial.

Setting

PICU of a tertiary care teaching hospital in India.

Patients

Consecutive children aged 1 month to 15 years who were mechanically ventilated.

Intervention

Children were randomized to either dexmedetomidine or midazolam and the doses were titrated to maintain target sedation score of 4 or 5 as measured by Penn State Children Hospital Sedation algorithm.

Outcome

The percentage of time spent in level 4 or 5 of Penn State Children Hospital sedation algorithm for ventilated children.

Results

49 children were randomized (24 to ‘midazolam group’ and 25 to ‘dexmedetomidine group’). There was no difference in the percentage of time spent in the targeted sedation between the groups [midazolam 67.3% (18.8) vs. dexmedetomidine 56.3 %. (28.6); P=0.12]. The absolute difference in the percentage of time spent was −10.9% [SE (95% CI) 7.05: (−25.15 to 3.25)]. The lower end of 95% CI for the difference breached the non-inferiority limit of −20%. Number of fentanyl boluses, duration of mechanical ventilation, ICU stay, and hospital stay were similar. Four (17.4%) children in dexmedetomidine group developed persistent bradycardia.

Conclusion

Non-inferiority of dexmedetomidine compared to midazolam for sedation in children on mechanical ventilation could not be established.

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Authors and Affiliations

  1. Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110 029, India

    Krishna Mohan Gulla, Jhuma Sankar, Kana Ram Jat, Sushil Kumar Kabra & Rakesh Lodha

Authors
  1. Krishna Mohan Gulla
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  2. Jhuma Sankar
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  3. Kana Ram Jat
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  4. Sushil Kumar Kabra
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  5. Rakesh Lodha
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Contributions

KMG: design of the study, patient management, data collection, data analysis, and preparation of manuscript; JS,KRG,SKK: design of the study, patient management, reviewed manuscript; RL: design of the study, patient management and reviewed manuscript.

Corresponding author

Correspondence to Rakesh Lodha.

Ethics declarations

Ethics clearance: The study was approved by Institute Ethics Committee, AIIMS, New Delhi; IECPG/403, dated June 29, 2016.

Competing interest: None stated.

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Gulla, K.M., Sankar, J., Jat, K.R. et al. Dexmedetomidine vs Midazolam for Sedation in Mechanically Ventilated Children: A Randomized Controlled Trial. Indian Pediatr 58, 117–122 (2021). https://doi.org/10.1007/s13312-021-2124-7

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  • DOI: https://doi.org/10.1007/s13312-021-2124-7

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