Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Dexmedetomidine

Generic name
Dexmedetomidine
Brand name
ATC Code
N05CM18

Pharmacokinetics in children

The following mean (95% confidence interval) pharmacokinetic parameters were found in a population kinetics analysis of 4 studies in children who received a loading dose of 0.05-1 microg/kg and a maintenance dose of 0.05-2 microg/kg/h administered postoperatively after cardiac surgery or for the purpose of sedation in the intensive care unit (FDA-Clinical_Pharmacology_Review, SmPC Dexdor):

Age CL (L/hour/kg) Vd (L/kg) T1/2 (h)
28 weeks GA to <1 month (n=28) 0,93 (0,76 – 1,14) 0,83 (0,72 – 0,95) 4,47 (3,81 - 5,25)
1 to <6 months (n=14) 1,21 (0,99 – 1,48) 0,76 (0,57 – 1,00) 2,05 (1,59 - 2,65)
6 to <12 months (n=15) 1,11 (0,94 – 1,31) 0,99 (0,75 – 1,31) 2,01 (1,81 - 2,22)
12 to <24 months (n=13) 1,06 (0,87 – 1,29) 0,72 (0,55 – 0,95) 1,97 (1,62 -  2,39)
2 to <6 years (n=26) 1,11 (1,00 – 1,23) 0,96 (0,76 – 1,21) 1,75 (1,57 - 1,96)
6 to <17 years (n=28) 0,80 (0,69 – 0,92) 0,80 (0,61 – 1,04) 2,03 (1,78 - 2,31)

Data from two pharmacokinetic studies additionally show the following mean steady state plasma concentrations after intravenous administration of 1 microg/kg in 10 minutes followed by continuous infusion of 0.7 microg/kg/hr to children postoperatively after cardiac surgery (n=36) or for the purpose of sedation in the intensive care unit (n=58):

Age Css (pg/mL)
1 to < 6 months 606
6 tot < 12 months 719
12 to < 24 months 696
2 to < 6 years 789
≥6 to 17 years 1203

After single administration to 18 children 6-44 months after elective cardiac surgery, the following Cmax and Tmax (median and range) were found (Miller et al. 2018):

Dose 1 microg./kg intranasal 2 microg./kg intranasal (n=6) 1 microg./kg IV (n=6)
Cmax (pg/mL) 182 (163 - 251) 324 (229 - 597) 783 (460-1030)
Tmax (min) 46,5 (31 - 62) 45,5 (32 - 65) -

In this study, a bioavailability of 83.8% was found for intranasal administration (95% confidence interval: 69.5-98.1).

In neonates undergoing hypothermia for hypoxic ischemic encephalopathy (HIE), the clearance of dexmedetomidine may be decreased and the volume of distribution increased (McAdams et al. 2020)

In children who have undergone cardiac surgery, clearance may be reduced (Potts et al. 2009, Greenberg et al. 2017)

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Sedation before or during diagnostic or surgical procedures in nonintubated patients
  • Nasal
    • 6 months up to 18 years
      • 2 - 3 microg./kg/dose Repeat if necessary, in total max. 200 microg.
    • 6 months up to 18 years
      [1] [2] [8]
      • 2 - 3 microg./kg/dose Repeat if necessary, in total max. 200 microg.
Analgosedation in the ICU
  • Intravenous
    • 1 month up to 18 years
      • Initial dose: 0.5 - 1 microg./kg/dose in 10 min.
      • Maintenance dose: 0.5 microg./kg/hour, continuous infusion dose according to effect and side effects until. Max: 1.4 microg./kg/hour.
        • Higher doses (up to 2.5 microg/kg/hr) have been described, and may be considered if elevation is hemodynamically tolerated.
        • Use of a loading dose (initial dose) is dependent on any concurrent use of other sedatives and the current and desired level of sedation.
    • Premature neonates Gestational age < 37 weeks
      • Initial dose: 0.2 - 0.3 microg./kg/dose in 10 min.
      • Maintenance dose: 0.2 - 0.3 microg./kg/hour, continuous infusion dose according to effect and side effects until. Max: 1 microg./kg/hour.

      • Use of a loading dose (initial dose) is dependent on any concurrent use of other sedatives and the current and desired level of sedation.

    • Term neonate
      • Initial dose: 0.3 - 0.5 microg./kg/dose in 10 min.
      • Maintenance dose: 0.3 - 0.5 microg./kg/hour, continuous infusion dose according to effect and side effects until. Max: 1.4 microg./kg/hour.

      • Use of a loading dose (initial dose) is dependent on any concurrent use of other sedatives and the current and desired level of sedation.

    • 1 month up to 18 years
      [19] [22] [23]
      • Initial dose: 0.5 - 1 microg./kg/dose in 10 min.
      • Maintenance dose: 0.5 microg./kg/hour, continuous infusion dose according to effect and side effects until. Max: 1.4 microg./kg/hour.
        • Higher doses (up to 2.5 microg/kg/hr) have been described, and may be considered if elevation is hemodynamically tolerated.
        • Use of a loading dose (initial dose) is dependent on any concurrent use of other sedatives and the current and desired level of sedation.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Some studies show an association between the use of dexmedetomidine and hypotension and/or bradycardia (Chrysostomou et al. 2009, Su et al. 2016, Pan et al. 2016). Potts et al. 2010 additionally describes a biphasic course of blood pressure, with initial hypotension followed by hypertension.

A single case of hypothermic bradycardia in a neonate has been reported in the literature [SmPC Dexdor].

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In obese children, based on limited data, dosing based on ideal body weight (IBW) is recommended (Ross et al. 2015).This can be calculated as follows: Ideal body weight (reflective of lean body mass in children (age 2-20)) = (50% BMI for age) x (height [m])2.

Do not treat any bradycardia in children with normal blood pressure with anticholinergics because of the risk of acute hypertension (Mason et al. 2009)

New-born infants may be particularly sensitive to the bradycardic effects of Dexmedetomidin in the presence of hypothermia and in conditions of heart rate-dependent cardiac output [SmPC Dexdor].

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Barbiturates, plain
N05CA01
Aldehydes and derivatives
N05CC01
Benzodiazepine derivatives
N05CD08
N05CD02
N05CD07
Other hypnotics and sedatives
N05CM21
Melatonin receptor agonists
N05CH01

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References

  1. Bua, J., et al, Intranasal dexmedetomidine, as midazolam-sparing drug, for MRI in preterm neonates., Paediatr Anaesth, 2018, 28 (8), 747-748
  2. Rao, Y., et al, The Effect of Dexmedetomidine on Emergence Agitation or Delirium in Children After Anesthesia-A Systematic Review and Meta-Analysis of Clinical Studies., Front Pediatr, 2020, 8, 329
  3. McAdams, R. M., et al, Dexmedetomidine Pharmacokinetics in Neonates with Hypoxic-Ischemic Encephalopathy Receiving Hypothermia, Anesthesiol Res Pract, 2020, 2020, 2582965
  4. Mason KP, et al., An exaggerated hypertensive response to glycopyrrolate therapy for bradycardia associated with high-dose dexmedetomidine., Anesth Analg, 2009, 108(3), 906-8
  5. Su, F., et al., Dexmedetomidine Pharmacology in Neonates and Infants After Open Heart Surgery, Anesth Analg, 2016, 122 (5), 1556-66
  6. Pasin, L., et al, Dexmedetomidine vs midazolam as preanesthetic medication in children: a meta-analysis of randomized controlled trials., Paediatr Anaesth, 2015, 25 (5), 468-76
  7. Ross, E. L., et al, Development of recommendations for dosing of commonly prescribed medications in critically ill obese children, Am J Health Syst Pharm, 2015, 72 (7), 542-56
  8. Lian, X., et al, Comparison of dexmedetomidine with chloral hydrate as sedatives for pediatric patients: A systematic review and meta-analysis, Medicine (Baltimore, 2020, 99 (31), e21008
  9. Pan, W.,et al, Outcomes of dexmedetomidine treatment in pediatric patients undergoing congenital heart disease surgery: a meta-analysis., Paediatr Anaesth, 2016, 26 (3), 239-48
  10. Chrysostomou, C., et al, Dexmedetomidine use in a pediatric cardiac intensive care unit: can we use it in infants after cardiac surgery, Pediatr Crit Care Med, 2009, 10 (6), 654-60
  11. FDA-Clinical_Pharmacology_Review., Pediatric Submission, https://www.fda.gov/media/86351/download, 12/17/2012, Access Date: Jan 2021
  12. Greenberg, R. G., et al, Population Pharmacokinetics of Dexmedetomidine in Infants, J Clin Pharmacol, 2017, 57 (9), 1174-1182
  13. Hauber, J. A., et al, Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children, Anesth Analg, 2015, 121 (5), 1308-15
  14. Jun, J. H., et al, The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis., Can J Anaesth, 2017, 64 (9), 947-961
  15. Miller, J. W., et al, Does intranasal dexmedetomidine provide adequate plasma concentrations for sedation in children: a pharmacokinetic study, Br J Anaesth, 2018, 120 (5), 1056-1065
  16. Potts, A. L., et al, Dexmedetomidine pharmacokinetics in pediatric intensive care--a pooled analysis., Paediatr Anaesth, 2009, 19 (11), 1119-29
  17. Potts AL, et al., Dexmedetomidine hemodynamics in children after cardiac surgery., Paediatr Anaesth, 2010, 20(5), 425-33
  18. Feng, J. F., et al, Effects of dexmedetomidine versus midazolam for premedication in paediatric anaesthesia with sevoflurane: A meta-analysis, J Int Med Res, 2017, 45 (3), 912-923
  19. Carroll, C. L., et al, Use of dexmedetomidine for sedation of children hospitalized in the intensive care unit., J Hosp Med, 2008, 3 (2), 142-7
  20. Dersch-Mills, D. A., et al, Dexmedetomidine Use in a Tertiary Care NICU: A Descriptive Study., Ann Pharmacother, 2019, 53 (5), 464-470
  21. Chrysostomou, C., et al., A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates, J Pediatr, 2014, 164 (2), 276-82
  22. Daverio, M.,et al, Dexmedetomidine for Prolonged Sedation in the PICU: A Systematic Review and Meta-Analysis., Pediatr Crit Care Med, 2020, 21 (7), e467-e474
  23. Hayden, J. C., et al, Efficacy of α2-Agonists for Sedation in Pediatric Critical Care: A Systematic Review, Pediatr Crit Care Med, 2016, 17 (2), e66-75
  24. O'Mara, K., et al, Dexmedetomidine versus standard therapy with fentanyl for sedation in mechanically ventilated premature neonates., J Pediatr Pharmacol Ther, 2012, 17 (3), 252-62
  25. Tsiotou, A. G., et al., Dexmedetomidine for the reduction of emergence delirium in children undergoing tonsillectomy with propofol anesthesia: A double-blind, randomized study, Paediatr Anaesth, 2018, 28 (7), 632-638
  26. Song, I. A., et al, Dexmedetomidine Injection during Strabismus Surgery Reduces Emergence Agitation without Increasing the Oculocardiac Reflex in Children: A Randomized Controlled Trial., PLoS One, 2016, 11 (9), e0162785

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