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

Interactions
PK
Renal impairment
References

Sufentanil

Generic name
Sufentanil
Brand name
ATC Code
N01AH03

Pharmacokinetics in children

Plasma protein binding is lower in children than in adults and increases with age. In  neonates, sufentanil is approximately 80.5% protein bound, compared with 88.5% in infants (n=13) and 91.9% in children. The clinical relevance of reduced protein binding in neonates and infants is unknown.

The pharmacokinetics of sufentanil after administration of an intravenous bolus of sufentanil of 10-15 mcg/kg to pediatric patients undergoing cardiac surgery, as in adults, can be described by a three-phase plasma concentration curve (see tabel below).  Pharmacodynamic differences due to differences in pharmacokinetic parameters may be greater if the unbound fraction is taken into account.

Pharmacokinetic parameters of sufentanil in children:

Age Plasma proteine binding % Vd (l/kg)   CL (ml/kg/min) 

 T1/2β (min)  Reference
Neonates (GA 39 (37-40) weeks, PNA 9(2-30)h, BW 3,18 (2,89-3,86) kg, N=12)a - 4,7 (4,1-5,4)a* 10,85 (7,22-12,52)a 798 (564-1002)a Pokorna 2021
Neonates (0-8 days N=3)b - 2,7 4,2 635 Greely 1988
Neonates (1-30 days, N=9)b 80,5 4,15 (1,01) 6,7 (6,1) 737 (346) SmPC Piramal; Greely 1987
Neonates (20-28 days, N=3)b - 3,4 17,3 217 Greely 1988
Infants (1-23 months, N=7)b 88,5 3,09 (0,95) 18,1 (2,8) 214 (41) SmPC Piramal; Greely 1987
Children (3-11 years, N=7)b 91,9 2,73 (0,50) 16,9 (3,2) 140 (30) SmPC Piramal; Greely 1987
Adolescents (12-18 years, N=5)b 2,75 (0,53) 13,1 (3,6) 209 (23) SmPC Piramal; Greely 1987

All pharmacokinetic values are presented as mean(SD), unless otherwise indicated.
ᵃ median [IQR], ᵇ Cardiovascular patients, undergoing surgery, *Vdc


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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

Analgosedation in mechanically ventilated patients
  • Intravenous
    • Gestational age < 37 weeks
        • Postnatal age 0-7 days
          Loading dose: 0,1-0,5 mcg/kg/dose in 15-20 min.
          Maintenance:0,02- 0,05 mcg/kg/hour continuous infusion.
        • Postnatal age ≥ 7 days
          Loading dose: 0,1-0,5 mcg/kg/dose in 15-20 min.
          Maintenance: 0,05-0,2 mcg/kg/hour continuous infusion.
    • Gestational age < 37 weeks
      [18] [20] [23] [25]
        • Postnatal age 0-7 days
          Loading dose: 0,1-0,5 mcg/kg/dose in 15-20 min.
          Maintenance:0,02- 0,05 mcg/kg/hour continuous infusion.
        • Postnatal age ≥ 7 days
          Loading dose: 0,1-0,5 mcg/kg/dose in 15-20 min.
          Maintenance: 0,05-0,2 mcg/kg/hour continuous infusion.
    • Term neonate
      [18] [20] [23] [25]
        • Postnatal age 0-7 days
          Loading dose: 0,1-0,5 mcg/kg/dose in 15-20 min.
          Maintenance:0,02- 0,1 mcg/kg/hour continuous infusion.
        • Postnatal age ≥ 7 days
          Loading dose: 0,1-0,5 mcg/kg/dose in 15-20 min.
          Maintenance: 0,05-0,4 mcg/kg/hour continuous infusion.
Procedural analgosedation during intubation
  • Intravenous
    • Term neonate
      • 0.2 - 0.3 microg./kg/dose, once only.
    • 1 month up to 18 years
      • 0.1 - 0.2 microg./kg/dose, once only.
    • Gestational age < 28 weeks
      • 0.1 - 0.2 microg./kg/dose, once only.
    • Gestational age ≥ 28 weeks
      • 0.2 - 0.3 microg./kg/dose, once only.
    • Term neonate
      [28]
      • 0.2 - 0.3 microg./kg/dose, once only.
    • 1 month up to 18 years
      [2] [8]
      • 0.1 - 0.2 microg./kg/dose, once only.
    • 1 month up to 18 years
      • 0.1 - 0.2 microg./kg/dose, once only.
Perioperative analgesia
  • Epidural
    • 1 year up to 18 years
      • Intra-operativ: 0.25 - 0.75 microg./kg/dose, once only.

      • Alternativ:
        Start: 0.1 mcg/kg bolus
        Maintenance: 0.03-0.3 mcg/kg/hr epidural infusion in combination with an amide local anaesthetic
        [SmPC Sufenta paragraph 5.1]

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

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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

Watch out for vagotonia, muscle rigidity and respiratory depression. Be cautious if there is elevated intracranial pressure, myasthenia gravis.

In neonates there is a risk of overdosing or underdosing after IV administration due to the large variation in pharmacokinetics.

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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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Halogenated hydrocarbons
N01AB07
N01AB06
N01AB08
Barbiturates, plain
N01AF03
Opioid anesthetics
N01AH02
N01AH01
N01AH06
Other general anesthetics
N01AX01
N01AX14
N01AX07
N01AX10

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References

  1. NVK Working group Neonatal Pharmacotherapy, Expert opinion, 28 sept 2023
  2. Rademaker C.M.A. et al, Geneesmiddelen-formularium voor Kinderen, 2007
  3. Piramal Critical Care B.V., SmPC Sufenta (RVG 09233) 03-02-2023, www.geneesmiddeleninformatiebank.nl
  4. Piramal Critical Care B.V., SmPC Sufenta, 50 Mikrogramm/ml Injektionslösung (7692.00.00), 06/2021
  5. Piramal Critical Care B.V., SmPC Sufenta mite, 5 Mikrogramm/ml Injektionslösung (7692.02.00), 06/2021
  6. Hameln Pharma GmbH, SmPC Sufentanil-hameln 10 Mikrogramm/ml, Injektions-/Infusionslösung (94564.00.00), 04/2020
  7. Davis PJ, et al., Pharmacokinetics of sufentanil in adolescent patients with chronic renal failure., Anesthesia and analgesia, 1988, 67(3), 268-71
  8. Bartkowska-Sniatkowska A, et al., Pharmacokinetics of sufentanil during long-term infusion in critically ill pediatric patients., Journal of clinical pharmacology., 2016, 56(1), 109-15
  9. Li N, et al., The optimal bolus dose of sufentanil for satisfactory laryngeal mask airway (LMA) insertion conditions in chinese pediatric patients: A prospective double-blind randomized controlled trial (CONSORT)., Medicine., 2019, 98(10), e14711
  10. Davis PJ, et al., Pharmacodynamics and pharmacokinetics of high-dose sufentanil in infants and children undergoing cardiac surgery. , Anesthesia and analgesia, 1987, 66(3), 203-8
  11. Guay J, et al., Pharmacokinetics of sufentanil in normal children, Canadian journal of anaesthesia (Journal canadien d'anesthesie), 1992, 39(1), 14-20
  12. Lejus C, et al., Fentanyl versus sufentanil: plasma concentrations during continuous epidural postoperative infusion in children., British journal of anaesthesia, 2000, 85(4), 615-7
  13. Woloszczuk-Gebicka B, et al , Pharmacokinetics of sufentanil administered with 0.2% ropivacaine as a continuous epidural infusion for postoperative pain relief in infants. , Paediatric anaesthesia, 2014, 24(9), 962-7
  14. Borsuk A, et al., Flip-Flop Phenomenon in Epidural Sufentanil Pharmacokinetics: A Population Study in Children and Infants., Journal of clinical pharmacology, 2017, 57(9), 1194-206
  15. Pokorná P, et al., Sufentanil pharmacokinetics in a full-term neonate treated with extracorporeal membrane oxygenation: a case report. , Perfusion, 2019, 34(5), 433-6
  16. Benlabed M, et al., Analgesia and ventilatory response to CO2 following epidural sufentanil in children., Anesthesiology, 1987, 67(6), 948-51
  17. Cho JE, et al., Epidural sufentanil provides better analgesia from 24 h after surgery compared with epidural fentanyl in children., Acta anaesthesiologica Scandinavica, 2008, 52(10), 1360-3
  18. Ross EL, 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
  19. Nguyen The Tich S, et al., Effects of sufentanil on electroencephalogram in very and extremely preterm neonates., Pediatrics, 2003, 111(1), 123-8
  20. Durrmeyer X,et al., Premedication before laryngoscopy in neonates: Evidence-based statement from the French society of neonatology (SFN)., Front Pediatr., 2022, 10, 1075184
  21. Soreze Y, et al., Reduced Sufentanil Doses are Effective for Postoperative Analgesia After Ductal Closure in Extremely Premature Infants: A 10 Years Retrospective Cohort Study., Clin J Pain, 2017, 33(12), 1109-16
  22. Greeley WJ, et al., Sufentanil pharmacokinetics in pediatric cardiovascular patients, Anesth Analg, 1987, 66(11), 1067-72
  23. Pokorná P, et al., Sufentanil Disposition and Pharmacokinetic Model-Based Dosage Regimen for Sufentanil in Ventilated Full-Term Neonates, Pharmacology, 2021, 106(7-8), 384-9
  24. Seguin JH,et al., Safety and efficacy of sufentanil therapy in the ventilated infant., Neonatal Netw., 1994, 13(4), 37-40
  25. Greeley WJ, de Bruijn NP., Changes in sufentanil pharmacokinetics within the neonatal period, Anesth Analg, 1988, 67(1), 86-90
  26. Schmidt B, et al., Comparison of sufentanil versus fentanyl in ventilated term neonates., Klin Padiatr., 2010, 222(2), 62-6
  27. Durrmeyer X, et al., Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial., Jama, 2018, 319(17), 1790-801
  28. Durrmeyer X, et al., Assessment of atropine-sufentanil-atracurium anaesthesia for endotracheal intubation: an observational study in very premature infants., BMC Pediatr, 2014, 14, 12
  29. Davis PJ, et al., Pharmacodynamics and pharmacokinetics of high-dose sufentanil in infants and children undergoing cardiac surgery., Anesthesia and analgesia, 1987, 66(3), 203-8
  30. Woloszczuk-Gebicka B, et al, Pharmacokinetics of sufentanil administered with 0.2% ropivacaine as a continuous epidural infusion for postoperative pain relief in infants., Paediatric anaesthesia, 2014, 24(9), 962-7
  31. Pokorná P, et al., Sufentanil pharmacokinetics in a full-term neonate treated with extracorporeal membrane oxygenation: a case report., Perfusion, 2019, 34(5), 433-6

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Changes

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