A Retrospective Comparison of Dexmedetomidine Versus Midazolam for Pediatric Patients with Congenital Heart Disease Requiring Postoperative Sedation

Jiang, Li; Ding, Sheng; Yan, Hong-tao; Li, Yunming; Zhang, Liping; Xue, Cong; Yin, Xia; Liu, Shunbi; Tang, Xiuying; Zhang, Jinbao

doi:10.1007/s00246-015-1110-z

Cited by 35 publications

(29 citation statements)

References 23 publications

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“…Of the remaining 28 eligible studies, 14 were removed because they reported on other outcomes, they were not full-text, or two publications used the same patients. Fourteen studies were included in the final meta-analysis (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33). The selection process is detailed in Figure 1.…”

Section: Literature Search and Study Selectionmentioning

confidence: 99%

“…All of the studies were published from 2006 to 2015; the sample sizes ranged from 14 to 1088, and the total number of patients was 2229 (dexmedeto-midine group, n = 1055; control group, n = 1174). Five of the included studies were RCTs (20)(21)(22)(23)(24), one was a post hoc analysis of RCTs (25), and the remaining eight were cohort studies (26)(27)(28)(29)(30)(31)(32)(33): four retrospective (26,29,30,33) and four prospective (27,28,31,32).…”

Section: Article Characteristicsmentioning

confidence: 99%

“…After pooling data from eight studies (20)(21)(22)25,26,29,30,32,33) that assessed postoperative mechanical ventilation in 2037 patients, it was found that dexmedetomidine significantly reduced the length of mechanical ventilation (MD À93.36; 95% CI À137.45, À49.27; P < 0.0001; Table 2). Our data also revealed no difference between the dexmedetomidinetreated and control patients in the length of ICU (MD À0.18; 95% CI À0.49, 0.13; P = 0.25) and hospital (MD 0.39; 95% CI À0.22, 1.01; P = 0.15) stays.…”

Section: Effects On Early Recoverymentioning

confidence: 99%

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Outcomes of dexmedetomidine treatment in pediatric patients undergoing congenital heart disease surgery: a meta‐analysis

Pan

Wang

Lin

et al. 2015

Pediatric Anesthesia

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What is already known • Dexmedetomidine is a safe and efficacious sedative agent, and can offer some benefit for adult patients undergoing cardiac surgery. What this article adds • Perioperative dexmedetomidine treatment improves the outcomes in children undergoing congenital heart disease surgery, including more stable hemodynamics, shorter ventilation duration, and lesser incidence of postop-erative agitation, and rescue analgesia. Summary Background: Dexmedetomidine decreases cardiac complications in adults undergoing cardiovascular surgery. This systematic review assessed whether perioperative dexmedetomidine improves congenital heart disease (CHD) surgery outcomes in children. Methods: The PubMed, Embase, and Cochrane Library databases were searched for randomized controlled trials (RCTs) or observational studies that were published until 16 April 2015 and compared dexmedetomidine with placebo or an alternative anesthetic agent during pediatric CHD surgery. The assessed outcomes included hemodynamics, ventilation length, intensive care unit (ICU) and hospital stays, blood glucose and serum cortisol levels, post-operative analgesia requirements, and postoperative delirium. Results: Five RCTs and nine observational studies involving 2229 patients were included. In pooled analyses, dexmedetomidine was associated with shorter length of mechanical ventilation (mean difference: À93.36, 95% CI: À137.45, À49.27), lower postoperative fentanyl (mean difference: À24.11, 95% CI: À36.98, À11.24) and morphine (mean difference: À0.07, 95% CI: À0.14, 0.00) requirements, reduced stress response (i.e., lower blood glucose and serum cortisol levels), and lower risk of delirium (OR: 0.39, 95% CI: 0.21, 0.74). The hemodynamics of dexmedetomidine-treated patients appeared more stable, but there were no significant differences in the ICU or hospital stay durations. Dexmedetomidine may increase the bradycardia and hypotension risk (OR: 3.14, 95% CI: 1.47, 6.69). Conclusions: Current evidence indicates that dexmedetomidine improves outcomes in children undergoing CHD surgery. However, this finding largely relies on data from observational studies; high-quality RCTs are warranted because of the potential for subject selection bias.

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Section: Literature Search and Study Selectionmentioning

confidence: 99%

Section: Article Characteristicsmentioning

confidence: 99%

Section: Effects On Early Recoverymentioning

confidence: 99%

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Outcomes of dexmedetomidine treatment in pediatric patients undergoing congenital heart disease surgery: a meta‐analysis

Pan

Wang

Lin

et al. 2015

Pediatric Anesthesia

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“…48 Other studies showed that the use of dexmedetomidine is safe in patients with congenital heart diseases and in the post-operatory of cardiac surgery without hypotension and bradycardia harmful to the patient. [49][50][51][52][53] Management of abstinence syndrome Prolonged administration of opioids and/or benzodiazepines leads to tolerance. Rapid suspension of these medications implicates a myriad of signs and symptoms, called abstinence syndrome.…”

Section: Resultsmentioning

confidence: 99%

Importance of the use of protocols for the management of analgesia and sedation in pediatric intensive care unit

Motta

Luglio²,

Delgado

et al. 2016

Rev. Assoc. Med. Bras.

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Summary Introduction: Analgesia and sedation are essential elements in patient care in the intensive care unit (ICU), in order to promote the control of pain, anxiety and agitation, prevent the loss of devices, accidental extubation, and improve the synchrony of the patient with mechanical ventilation. However, excess of these medications leads to rise in morbidity and mortality. The ideal management will depend on the adoption of clinical and pharmacological measures, guided by scales and protocols. Objective: Literature review on the main aspects of analgesia and sedation, abstinence syndrome, and delirium in the pediatric intensive care unit, in order to show the importance of the use of protocols on the management of critically ill patients. Method: Articles published in the past 16 years on PubMed, Lilacs, and the Cochrane Library, with the terms analgesia, sedation, abstinence syndrome, mild sedation, daily interruption, and intensive care unit. Results: Seventy-six articles considered relevant were selected to describe the importance of using a protocol of sedation and analgesia. They recommended mild sedation and the use of assessment scales, daily interruptions, and spontaneous breathing test. These measures shorten the time of mechanical ventilation, as well as length of hospital stay, and help to control abstinence and delirium, without increasing the risk of morbidity and morbidity. Conclusion: Despite the lack of controlled and randomized clinical trials in the pediatric setting, the use of protocols, optimizing mild sedation, leads to decreased morbidity.

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“…The results of a meta-analysis that compared use of dexmedetomidine with placebo or other alternative anesthetic agents during pediatric congenital heart disease surgery suggested that dexmedetomidine was associated with shorter length of mechanical ventilation, lower post-operative fentanyl and morphine requirements, reduced stress response, and lower risk of delirium (Pan et al, 2016 ). Similarly, in a retrospective comparison in pediatric patients with congenital heart disease requiring post-operative sedation, patients who received dexmedetomidine required significantly lower doses of adjunctive sedative/analgesic drugs compared with those who received midazolam (Jiang et al, 2015 ).…”

Section: Discussionmentioning

confidence: 99%

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation

Jooste

Hammer

Reyes³

et al. 2017

Front. Pharmacol.

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Dexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Patients received one of two doses dependent on age: patients aged ≥28 weeks' gestational age to <1 month postnatal received dose level 1 (0.1 μg/kg load; 0.05–0.2 μg/kg/h infusion); those aged 1 month to <17 years received dose level 2 (1 μg/kg load; 0.2–2.0 μg/kg/h infusion). Sedation efficacy was assessed and defined as adequate sedation for at least 80% of the time and successful completion of the procedure without the need for rescue medication. In all, 91 patients were enrolled (dose level 1, n = 1; dose level 2, n = 90); of these, 90 received treatment and 82 completed the study. Eight patients in dose level 2 discontinued treatment for the following reasons: early completion of diagnostic or therapeutic procedure (n = 3); change in medical condition (need for intubation) requiring deeper level of sedation (n = 2); adverse event (AE; hives and emesis), lack of efficacy, and physician decision (patient not sedated enough to complete procedure; n = 1 each). Sixty-seven patients experienced 147 TEAEs. The two most commonly reported AEs were respiratory depression (bradypnea; reported per protocol-defined criteria, based on absolute respiratory rate values for age or relative decrease of 30% from baseline) and hypotension. Four patients received glycopyrrolate for bradycardia and seven patients received intravenous fluids for hypotension. SpO2 dropped by 10% in two patients, but resolved without need for manual ventilation. All other reported AEs were consistent with the known safety profile of dexmedetomidine. Two of the 78 patients in the efficacy-evaluable population met all sedation efficacy criteria. Dexmedetomidine was well-tolerated in pediatric patients undergoing procedure-type sedation.

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A Retrospective Comparison of Dexmedetomidine Versus Midazolam for Pediatric Patients with Congenital Heart Disease Requiring Postoperative Sedation

Cited by 35 publications

References 23 publications

Outcomes of dexmedetomidine treatment in pediatric patients undergoing congenital heart disease surgery: a meta‐analysis

Outcomes of dexmedetomidine treatment in pediatric patients undergoing congenital heart disease surgery: a meta‐analysis

Importance of the use of protocols for the management of analgesia and sedation in pediatric intensive care unit

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation

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