Original Article

Yonsei Med J 2025 Aug;66(8):473-481

https://doi.org/10.3349/ymj.2024.0299 pISSN: 0513-5796 · eISSN: 1976-2437

Dexmedetomidine in Mechanically Ventilated Critically

Ill Children: A Systematic Review and Meta-Analysis
of Randomized Controlled Trials
In Kyung Lee1*, Kyeong Hun Lee2*, Hye-ji Han3, In Young Choi3, Na Jin Kim4, and Kyunghoon Kim3,5
1
Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul;
2
Department of Pediatrics, Seoul St. Mary’s Hospital, Seoul;
3
Department of Pediatrics, Seoul National University Bundang Hospital, Seongnam;
4
Medical Library, The Catholic University of Korea, Seoul;
5
Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.

Purpose: Children undergoing mechanical ventilation (MV) in the pediatric intensive care unit (PICU) require effective sedation to
reduce anxiety and discomfort. Dexmedetomidine, an α2-receptor agonist, presents as a viable sedative alternative. However, its
clinical outcomes for critically ill, mechanically ventilated children remain to be fully established. We performed a systematic review
and meta-analysis of randomized controlled trials (RCTs) to assess the clinical outcomes and adverse effects of dexmedetomidine in
such patients.
Materials and Methods: A systematic search was conducted up to April 2024. RCTs that compare dexmedetomidine with other
sedatives in mechanically ventilated children were included. This analysis focused on both the clinical and safety outcomes through
meta-analysis.
Results: Included in the analysis were eight trials, involving a total of 387 mechanically ventilated children. Compared to other sed-
atives, dexmedetomidine reduced the duration of MV [mean difference -3.54 hours; 95% confidence interval (CI), -6.49 to -0.59],
particularly in post-operative patients and when compared to fentanyl. However, dexmedetomidine did not significantly impact
the length of ICU stay, duration of sedation, or the necessity for additional sedatives. Dexmedetomidine was associated with a sig-
nificantly increased risk of bradycardia [odds ratio (OR) 6.14; 95% CI, 2.20 to 17.12] and hypotension (OR 8.14; 95% CI, 1.37 to
48.31) compared to other sedatives.
Conclusion: Although dexmedetomidine notably diminished the duration of MV, the potential for adverse effects necessitates
further investigation. Large RCTs are needed to validate our findings and refine sedation management in mechanically ventilated
children in PICU.

Key Words: ‌Dexmedetomidine, mechanical ventilation, sedation, pediatric, intensive care unit

Received: September 27, 2024 Revised: February 6, 2025

INTRODUCTION
Accepted: March 7, 2025 Published online: May 19, 2025
Corresponding author: Kyunghoon Kim, MD, PhD, Department of Pediatrics, Seoul Mechanically ventilated children are at a high risk of unplanned
National University College of Medicine, 172 Dolma-ro, Bundang-gu, Seongnam extubation, which can lead to airway injuries and life-threaten-
13605, Korea. ing scenarios like asphyxia.1-3 Effective sedation and analgesia
E-mail: journey237@snu.ac.kr
are important in managing these patients to not only reduce
*In Kyung Lee and Kyeong Hun Lee contributed equally to this work.
anxiety and discomfort from endotracheal tubes and intensive
•The authors have no potential conflicts of interest to disclose.
care unit (ICU) procedures but also to improve their overall
© Copyright: Yonsei University College of Medicine 2025
This is an Open Access article distributed under the terms of the Creative Com-
care outcomes.4-7
mons Attribution Non-Commercial License (https://creativecommons.org/licenses/ The concept of “analgosedation” in the pediatric intensive
by-nc/4.0) which permits unrestricted non-commercial use, distribution, and repro- care unit (PICU) is a sedation strategy that combines both anal-
duction in any medium, provided the original work is properly cited.
gesia and sedation to enhance the comfort of critically ill pa-

www.eymj.org 473
 Dexmedetomidine in PICU

tients.8 Despite its critical importance, the management of ers (IKL and KHL) to identify trials potentially eligible for in-
sedation in the PICU is challenging due to the absence of stan- clusion, with full texts being subsequently evaluated for eligi-
dardized protocols specifically designed for pediatric patients. bility. Discrepancies between reviewers were resolved through
Traditional sedatives such as benzodiazepines and propofol, discussion or by consulting a third reviewer as necessary.
though commonly administered to mechanically ventilated
critically ill children, carry the risk of tolerance, dependency, Inclusion criteria
and withdrawal symptoms.9,10 Included were trials that: 1) were RCTs; 2) involved critically ill
Dexmedetomidine presents as a favorable alternative seda- children, defined as invasively mechanically ventilated children
tive, recognized for providing milder sedation levels, decreasing (age ≤18 years) admitted to the ICU; 3) had an intervention
delirium, and possessing analgesic qualities. This highly selec- group receiving intravenous dexmedetomidine; and 4) had a
tive α2-receptor agonist, endorsed by the Food and Drug Ad- control group receiving other intravenous sedatives.
ministration for use in pediatric patients since 2013, achieves its
analgesic effect through the activation of α2-adrenoreceptors in Exclusion criteria
both the spinal and supraspinal areas.11 Extensively employed Excluded were trials that: 1) were observational studies, case
in surgical anesthesia and ICU sedation, dexmedetomidine is reports, letters, editorials, or were not peer-reviewed; 2) includ-
acclaimed for its analgesic, sedative, and anti-sympathetic ed duplicate samples; 3) had participants restricted to neonates
characteristics. In adults, compared to midazolam or propofol, or adults; 4) used dexmedetomidine solely during anesthesia
dexmedetomidine has shown advantages such as shortened or before procedures; 5) administered dexmedetomidine
duration of mechanical ventilation (MV), enhanced ease of through non-intravenous routes; or 6) used placebo for the con-
arousal, better patient cooperation, and improved communi- trol group.
cation.12
Although there is substantial evidence supporting the use Outcomes
of dexmedetomidine in adult populations,13-15 research con- The primary outcome focused on clinical measures such as
cerning its clinical outcomes in critically ill pediatric patients duration of MV, length of ICU stays, duration of sedation, and
on MV remains scarce. We performed a systematic review and total fentanyl bolus administrations. Secondary outcomes in-
meta-analysis of randomized controlled trials (RCTs) to assess cluded adverse effects such as bradycardia and hypotension.
the clinical outcomes of dexmedetomidine in critically ill chil-
dren on MV. Quality assessment
The risk of bias in the included trials was assessed by two re-
viewers (IKL and KHL) using a modified version of the Co-
MATERIALS AND METHODS chrane risk of bias tool.17 Each trial was examined for bias across
various domains, with each domain assessed as having low,
Study design unclear, or high risk of bias. The classification of the overall risk
A systematic review of RCTs comparing dexmedetomidine with of bias for each trial was as follows: low if the risk of bias was
other sedatives in critically ill, mechanically ventilated children low or possibly low in all domains, unclear if there was an un-
was conducted. A meta-analysis was also performed to evalu- clear risk of bias in at least one domain with no domain having
ate the efficacy and safety of dexmedetomidine. This study was a high risk of bias, or high if there was a high or possibly high risk
conducted in accordance with the Preferred Reporting Items of bias in at least one domain. Any discrepancies were resolved
for Systematic Reviews and Meta-Analyses (PRISMA) guide- through discussion and consensus between the reviewers.
lines.16
As this study involved the analysis of previously published Statistical analysis
data, institutional review board (IRB) was not required. The meta-analysis was conducted using R version 4.2.2 (R
Foundation for Statistical Computing, Vienna, Austria) with the
Database and search strategy “meta” and “metafor” packages to analyze the efficacy and ad-
A meticulously designed peer-reviewed search strategy was de- verse effects of dexmedetomidine in terms of sedation. For con-
veloped by a medical librarian (NJK). Searches were conducted tinuous outcome data, the mean difference (MD) served as the
in PubMed, Embase, and the Cochrane Library from their in- primary measure, with estimates aggregated using the inverse
ception up to April 4, 2024, utilizing terms related to dexme- variance method. The Mantel-Haenszel method was used to
detomidine and pediatric age. The details of this search strategy pool estimates for binary outcome data, employing odds ratio
are provided in Supplementary Table 1 (only online). (OR) and risk ratio as the primary metrics. Due to the hetero-
geneity among the included studies, a random effects model
Data collection and analysis was selected for conducting this meta-analysis.
Titles and abstracts were screened by two independent review-

474 https://doi.org/10.3349/ymj.2024.0299
In Kyung Lee, et al.

RESULTS was shown to reduce the duration of MV compared to other

sedative drugs [MD -3.54 hours, 95% confidence interval (CI),
Study selection and characteristics -6.49 to -0.59] (Fig. 3A).
Initially, searches of reference databases identified a total of The subgroup analysis indicated that dexmedetomidine con-
348 records. After the screening and eligibility assessment siderably shortened the MV duration in comparison to fentanyl
were conducted, eight studies18-25 satisfied the inclusion crite- (MD -1.53 h; 95% CI, -1.92 to -1.13) (Fig. 3B). Nevertheless, no
ria and were thus included in the meta-analysis (Fig. 1). significant disparities in MV duration were found when dexme-
Of the studies selected, five concentrated on post-operative detomidine was compared to midazolam (MD -14.58 h; 95%
pediatric patients, whereas the others enrolled medical pa- CI, -34.11 to 4.94) (Fig. 3C).
tients. The detailed characteristics of each study are outlined in Furthermore, dexmedetomidine significantly decreased MV
Table 1. Importantly, children with atrioventricular block were duration in post-operative patients (MD -4.22 h; 95% CI, -6.15
excluded from four of these studies (Supplementary Table 2, to -2.28) (Fig. 4A), but not in medical patients (MD -8.18 h; 95%
only online). CI, -46.57 to 30.20) (Fig. 4B).
Regarding interventions, most of the studies (7/8, 88%) did
not implement a dexmedetomidine bolus at the onset of the ICU length of stay
infusion. Moreover, dexmedetomidine was the exclusive sed- Eligible data from three studies were included in the meta-anal-
ative agent employed in most of the studies (7/8, 88%). ysis concerning the ICU length of stay. Dexmedetomidine, in
With respect to the control groups, the included trials exhib- comparison to other sedative drugs, showed no significant dif-
ited variability. Namely, three trials (3/8, 38%) used midazol- ference in the length of stay in the ICU (MD -0.20; 95% CI, -1.89
am, the same number employed fentanyl, and the remaining to 1.49) (Fig. 5A).
two trials (2/8, 25%) utilized combinations of different sedative
medications. Duration of sedation
Analysis of data from four studies on sedation duration re-
Risk of bias vealed no significant reduction when compared to other sed-
The risk of bias for the included studies is depicted in Fig. 2. atives (MD 0.16; 95% CI, -0.82 to 1.13) (Fig. 5B).

Clinical outcomes Number of fentanyl bolus doses

Data on the requirement for additional fentanyl boluses were
MV duration available from three trials. No significant reduction in the need
Data from seven studies were incorporated into the meta-analy- for fentanyl boluses was observed when compared to other
sis for the duration of MV. One study18 was excluded due to in- sedatives (MD -0.66; 95% CI, -2.73 to 1.40) (Fig. 5C).
sufficient extractable data for MV duration. Dexmedetomidine

Records identified through databases searching (n=348)

Identification

• Pubmed (n=79)
• EMBASE (n=136)
• Cochrane library (n=133)

Records after duplicates removed (n=251)

Screening

Records excluded by title and abstract

Records screened (n=251) screening (n=228)

Records excluded (n=15)

Eligibility

• Wrong patient population (n=3)

Records assessed for eligibility (n=23) • Wrong intervention (n=4)
• Wrong control (n=4)
• Not in English (n=2)
• Duplicate (n=1)
• Abstract only (n=1)
Included

Studies included for synthesis (n=8)

Fig. 1. Flowchart of study selection process.

https://doi.org/10.3349/ymj.2024.0299 475
 Table 1. Characteristics of the Included Studies

476
Inclusion Number of Age of Intervention Control group
Author Primary disease Initiation of DEX Termination of DEX
criteria patients (I/C) patients (I/C) group (dose) (dose)

Tobias, 200418 Patients admitted to Children and 30 (20/10) 39/36 DEX (0.25 mcg/kg/h or Midazolam (0.1 mg/kg/h) After intubation After 24 hours on either sedation
PICU requiring MV infants months† 0.5 mcg/kg/h) if MV was still necessary, the
patient was switched to the
alternative agent

Prasad, 201219 Patients undergoing 1–14 years, 60 (30/30) 6.07/5.67 DEX (0.5 mcg/kg/h) Fentanyl (1 mcg/kg/h) In the post-operative 6AM on the following day to allow
CHD surgery overnight years† intensive care unit an early extubation trial
MV was
anticipated

Aydogan, 201320 Patients undergoing 12–18 years 32 (16/16) 13.6/14.8 DEX (0.4 mcg/kg/h) Midazolam (0.1 mg/kg/h) After surgery At the time of extubation
scoliosis surgery years‡ Up to 24 hours on either sedation if
MV was still necessary

Saleh, 201621 Patients scheduled for 1–10 years, 50 (25/25) 6.12/5.68 DEX (0.3 mcg/kg/h) Fentanyl (1 mcg/kg/h) At arrival to the After 18 hours
†
abdominal surgery overnight years SICU
MV was
anticipated

Garisto, 201822 Patients undergoing 1–24 months 48 (22/26) 4.5/5.5 DEX (0.5 mcg/kg/h), Midazolam (0.1 mg/kg/h), After CCU admission Sedative drug weaning proceeded
‡
complex CHD surgery months midazolam (0.05 mg/kg/h), morphine (20 mcg/kg/h), with MV weaning, according to
morphine (10 mcg/kg/h), paracetamol bolus institutional guidelines
paracetamol bolus (7.5–15 mg/kg q6 hours)
(7.5–15 mg/kg q6 hours)

Erickson, 202023 Patients admitted to <16 years 60 (29/31) 16/3 DEX (1.0 mcg/kg/h) Usual care: propofol, After randomization Until sedation was no longer
‡
PICU requiring MV months benzodiazepines, chloral required or to a maximum of
hydrate, ketamine, and 14 days after enrollment
barbiturates
24
Gulla, 2021 Patients admitted to 1 month– 47 (23/24) 8/5.5 DEX (0.25–0.75 mcg/kg/h) Midazolam (1–4 mcg/kg/min) After randomization Until 7 days or weaning from MV
‡
PICU requiring MV 15 years months
25
Attia, 2022 Patients undergoing 1 day–15 years 60 (30/30) 28.3/25.7 DEX* (0.2–1.5 mcg/kg/h) Fentanyl (1–3 mcg/kg/h) During anesthesia No information available
†
CHD surgery months
I/C, intervention/control; PICU, pediatric intensive care unit; MV, mechanical ventilation; CHD, congenital heart disease; DEX, dexmedetomidine; SICU, surgical intensive care unit; CCU, cardiac intensive care unit.

https://doi.org/10.3349/ymj.2024.0299
Dexmedetomidine in PICU

*Dexmedetomidine was started with a bolus dose; †Mean values; ‡Median values.
In Kyung Lee, et al.

Safety outcomes
Four trials contributed data for the analysis of bradycardia in-
cidence, while two trials provided data for the analysis of hy-
potension incidence. Compared to other sedatives, dexme-
detomidine was significantly associated with a higher risk of
bradycardia (OR 4.55; 95% CI, 1.51 to 13.69) (Fig. 6A) and hy-
potension (OR 6.20; 95% CI, 1.01 to 38.07) (Fig. 6B).

Publication bias
The funnel plot for MV duration suggests potential publica-
tion bias and study heterogeneity due to its asymmetry (Sup-
plementary Fig. 1, only online).

DISCUSSION
This systematic review and meta-analysis, encompassing eight
trials with 387 mechanically ventilated children, provides evi-
dence that dexmedetomidine reduces MV duration in this
Fig. 2. Risk of bias of included studies. population, particularly in post-operative children and when

A MV duration

B MV duration: fentanyl

C MV duration: midazolam

Fig. 3. A forest plot comparing the duration of MV between (A) dexmedetomidine and alternative sedatives, (B) dexmedetomidine and fentanyl, (C) dex-
medetomidine and midazolam. MV, mechanical ventilation; IV, inverse variance; MD, mean difference; CI, confidence interval.

https://doi.org/10.3349/ymj.2024.0299 477
 Dexmedetomidine in PICU

A MV duration: post-operative

B MV duration: medical

Fig. 4. A forest plot comparing the duration of MV in (A) post-operative children and (B) medical children. MV, mechanical ventilation; IV, inverse variance;
MD, mean difference; CI, confidence interval.

A ICU LOS

B Sedation duration

C Fentanyl bolus

Fig. 5. A forest plot comparing (A) ICU length of stay, (B) duration of sedation, and (C) the number of fentanyl boluses between dexmedetomidine and oth-
er sedatives. ICU, intensive care unit; IV, inverse variance; MD, mean difference; CI, confidence interval.

478 https://doi.org/10.3349/ymj.2024.0299
In Kyung Lee, et al.

A Bradycardia

B Hypotension

Fig. 6. A forest plot comparing (A) bradycardia events and (B) hypotension events between dexmedetomidine and other sedatives. MH, mantel-haenszel;
OR, odds ratio; CI, confidence interval.

compared to fentanyl. However, dexmedetomidine did not previous analyses that concentrated primarily on the safety pro-
demonstrate significant effects on the length of ICU stays, du- file of dexmedetomidine.29
ration of sedation, or the need for additional sedatives. More- In subgroup analysis, dexmedetomidine significantly de-
over, dexmedetomidine was associated with a significantly creased MV duration in post-operative children for 4.22 hours.
higher risk of bradycardia and hypotension compared to other Conversely, no significant impact was observed in medical pa-
sedatives. tients, suggesting that the benefits of dexmedetomidine may
Several hypotheses offer explanations for how dexmedeto- be limited to post-operative settings. The clinical relevance of a
midine may improve MV duration. Firstly, dexmedetomidine 4.22-hour reduction may be debatable. However, in post-oper-
has been found to enhance compliance, reduce resistance, and ative patients, the 4.22-hour reduction could potentially impact
improve oxygenation during ongoing MV, potentially leading clinical practice. Furthermore, dexmedetomidine significantly
to a quicker extubation time.26 Secondly, dexmedetomidine’s decreased MV duration when compared to fentanyl, a com-
unique pharmacologic profile, including easy arousability and monly used opioid in pediatric critical care. This suggests that
minimal respiratory depression, may facilitate effective seda- dexmedetomidine could be a viable alternative to opioid-based
tion while minimizing complications associated with respi- sedation strategies, potentially reducing opioid use in the PICU.
ratory suppression.27 Furthermore, dexmedetomidine has Further research is needed to determine its efficacy across dif-
been linked to a reduced risk of adverse events like delirium in ferent patient populations and clinical scenarios.
adults,13 possibly aiding in a smoother extubation process. Additionally, our analysis distinctly focused on trials compar-
Our study builds upon previous meta-analyses in various ing dexmedetomidine with other sedatives, deliberately ex-
important aspects. Prior meta-analyses have mainly concen- cluding those comparisons with placebo. This decision was
trated on the efficacy of dexmedetomidine in specific pediatric made under the rationale that placebo-controlled trials might
cohorts, such as those undergoing cardiac surgery.28 Our in- not reflect the practical clinical conditions where dexmedeto-
vestigation, conversely, broadens this scope to include both midine is usually compared against active sedatives. While pla-
post-operative and medical pediatric populations, although cebo-controlled trials are informative regarding dexmedetomi-
dexmedetomidine only reduced MV duration in post-opera- dine’s specific effects, our intentional exclusion stems from our
tive children. Unlike the previous meta-analysis that limited its objective to evaluate dexmedetomidine’s relative effectiveness
focus to post-operative children,28 we excluded studies that ad- against common clinical interventions.
ministered dexmedetomidine only during anesthesia to evalu- Our study also showed a heightened risk of bradycardia and
ate its clinical effects in the context of MV in PICU settings. Fur- hypotension linked to dexmedetomidine, consistent with find-
thermore, our meta-analysis assesses both the sedation clinical ings from previous research. Acting through α-2a receptor ago-
outcomes and the adverse effects of dexmedetomidine, unlike nism, dexmedetomidine induces sedation by decreasing plas-

https://doi.org/10.3349/ymj.2024.0299 479
 Dexmedetomidine in PICU

ma norepinephrine levels, potentially causing bradycardia and hoon Kim. Resources: Na Jin Kim. Software: In Young Choi. Supervi-
hypotension.30 Despite noting these adverse effects, it is still sion: Kyunghoon Kim. Validation: In Kyung Lee and Kyunghoon Kim.
Visualization: Hye-ji Han. Writing—original draft: In Kyung Lee and
ambiguous whether they were reversible with non-invasive in-
Kyeong Hun Lee. Writing—review & editing: Kyunghoon Kim. Ap-
terventions or required vasoactive agents for management. Ad- proval of final manuscript: all authors.
ditionally, the dose-dependency of these adverse events de-
serves further exploration. Previous studies have indicated that
bradycardia and hypotension are infrequent in critically ill chil-
ORCID iDs
dren treated with dexmedetomidine for extended periods and In Kyung Lee https://orcid.org/0000-0002-4962-3810
are typically reversible with minimal interventions.29 Kyeong Hun Lee https://orcid.org/0000-0003-1610-8641
Challenges emerged in evaluating delirium within our meta- Hye-ji Han https://orcid.org/0000-0002-9103-8631
analysis due to scarce data on this outcome. Among the includ- In Young Choi https://orcid.org/0009-0004-0294-7190
Na Jin Kim https://orcid.org/0000-0001-7280-9579
ed studies, only two explored the assessment of delirium,20,23
Kyunghoon Kim https://orcid.org/0000-0002-0707-6839
with a single study focusing primarily on adolescent partici-
pants.20 Although meta-analyses involving adults have under-
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