- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The following pharmacokinetic parameters are reported by the SmPC:
| Cl (ml/kg/min)* | Vss (l/kg)* | T½ (h)* | |
| Infants 48-71 days post partum | 21,9 - 32,3 | 6,0 - 9,5 | 3,1 - 15,5 |
| Children 3,17 ± 0,68 years | 11,5 ± 4,19 | 3,06 ± 1,02 | 4,1 ± 1,3 |
| Adolescents 12 ± 1,73 years | 7,05 ± 1,24 | 1,92 ± 1,04 | 3,5 ± 1,2 |
| Adults | 5,7 | 6-8 |
* Steady-state clearance and volume of distribution values have been normalized for body weight.
Farmacokinetic parameters in neonates:
| Reference | Gestational age | Postnatal age | Dose (i.v.) | Cl | VdSS (L/kg) | T½ (hour) |
| SmPC ( Fentanyl Kalceks and Fentanyl Piramal) | Unknown | 1-26 days | unknown | 3,4-58,7 ml/kg/min | 1,3-30.,3 | 1,3-15,9 |
| Saarenmaa 2000 (n = 38) | 26-42 weeks, median 32 weeks | Median 10 hours | Loading dose: 10,5 mcg/kg over 1 hour, followed by continuous infusion 1,5 mcg/kg/hour | Mean 11,5 ± 4,0 (range: 4,6-18,5) ml/kg/min | - | - |
| Abiramalatha 2019 (CI: n-53) (IB: n=47) | Mean: CI: 36,5 (SD 4,6) weeks IB: 35,4 (SD 4,0) weeks | Median: CI: 1 day; IB:2 days | CI: 1 mcg/kg loading dose, followed by 1 mcg/kg/hour IB: 6 mcg/kg/day in 6 doses, dosing intervals 4 hours |
Median CI: 4,1 (2.0-6.4) L/hour . This equals appr. 28,1 ml/kg/min. | - | Median CI: 8,4 (Range 7,9-9,7) hours IB: 26,7 (8,1 - 65,2) hours |
| Völler 2019 (n = 98) | Median 26,9 weeks (range: 23,9-31,9) | Median: 3 days (range: 0-68) | PNA 0-4 days: 0,5 mcg/kg/hour PNA 5-9 days: 0,8 mcg/kg/hour (dose recommendations derived from popPK model) |
Estimated: 0,415 L/hour .This equals appr. 6,9 ml/kg/min. | Estimated V in central compartment: 8,68 L | - |
| Wu 2022 (pooled data from Völler 2019 and Saarenmaa 2000) (n = 164) | median: 28,95 weeks (range: 23,90-42,30 weeks) | median: 1,1 day (range: 0-68 days) | See Saarenmaa 2000 and Völler 2019 | Estimated: 0,573 L/hourThis equals appr. 8,2 ml/kg/min. |
CI = Continuous infusion; IB= Intermittent bolus
The clearance (11.5 ml/min/kg) in neonates is correlated significantly with gestational age and birthweight. (Saarenmaa 2000: continuous IV, N=38, gestational age 26-42 weeks)
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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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General Dose Info
In obese children, use adjusted body weight to calculate initial dose, thereafter increase or decrease dose based on efficacy and safety.
Dosages
| Pain |
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| Analgesia in intubated patients (intensive care) |
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| Analgesia as part of general anesthesia in intubated and ventilated patients |
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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 in children
After discontinuing prolonged infusions of fentanyl, children have experienced movement disorders, extraordinary sensitivity to stimuli and opiate-deprivation-like symptoms. [SmPC Fentanyl Hexal, SmPC Fentanyl-Piramal]
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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
Severe inhibitors of CYP3A4 such as erythromycin, ketoconazole, itraconazole, fluconazole or ritonavir can raise the plasma concentration of fentanyl.
Chest wall rigidity may occur in children under 2 years of age on low doses of fentanyl; (Dewhirst 2012)
Clearance of fentanyl is absent in neonates during the first 0-4 days of life. Cautious (low) dosing is indicated during the first week after birth, especially in premature neonates with gestational age < 32 weeks.
Repeated administration at short intervals over longer periods of time can lead to the development of a withdrawal syndrome after the end of treatment (SmPC).
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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 | ||
| N01AH06 | ||
| N01AH03 | ||
| Other general anesthetics | ||
|---|---|---|
| N01AX01 | ||
| N01AX14 | ||
| N01AX07 | ||
| N01AX10 | ||
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References
- Anand KJ, et al., Consensus statement for the prevention and management of pain in the newborn, Arch Pediatr Adolesc Med, 2001, 155(2), 173-80
- Johnson KL, et al, Fentanyl pharmacokinetics in the pediatric population., Anesthesiology, 1984, 61, A441
- Mercadante S, Cancer pain management in children., Palliat Med, 2004, 18, 654-62
- Mukherjee K. et al, Adenotonsillectomy in children: a comparison of morphine and fentanyl for peri-operative analgesia., Anaesthesia, 2001, 56(12):, 1193-7
- Pasero C, Fentanyl for acute pain management., J Perianesth Nurs, 2005, 20(4), 279-84
- Rajamani A, et al, A comparison of bilateral infraorbital nerve block with intravenous fentanyl for analgesia following cleft lip repair in children, Paediatr Anaesth, 2007, 17(2), 133-9
- Saarenmaa E, et al, Gestational age and birth weight effects on plasma clearance of fentanyl in newborn infants, J Pediatr., 2000, 136(6), 767-70
- Santeiro ML, et al, Pharmacokinetics of continuous infusion fentanyl in newborns, J Perinatol, 1997, 17(2), 135-9
- Werkgroep Neonatale Farmacologie NVK sectie Neonatologie., Expert opinie, 13 november 2018
- Abiramalatha T, et al., Continuous infusion versus intermittent bolus doses of fentanyl for analgesia and sedation in neonates: an open-label randomised controlled trial., Archives of disease in childhood Fetal and neonatal edition, 2019, 104(4), F433-F9
- Kalceks, SmPC Fentanyl Kalceks 0,05 mg/ml, oplossing voor injectie (RVG 119760) 21-03-24, www.geneesmiddelinformatiebank.nl
- Piramal Critical Care BV., SmPC Fentanyl-Piramal oplossing voor injectie 0,05 mg/ml (RVG 04748) 22-03-2024, www.geneesmiddelinformatiebank.nl
- Wu Y, et al., Pre- and Postnatal Maturation are Important for Fentanyl Exposure in Preterm and Term Newborns: A Pooled Population Pharmacokinetic Study., Clin Pharmacokinet., 2022, 61(3), 401-12
- Abiramalatha T, et al., Continuous infusion versus intermittent bolus doses of fentanyl for analgesia and sedation in neonates: an open-label randomised controlled trial., Arch Dis Child Fetal Neonatal Ed., 2019, 104(4), F433-f9
- Völler S, et al., Rapidly maturing fentanyl clearance in preterm neonates. , Arch Dis Child Fetal Neonatal Ed., 2019, 104(6), 598-603
- Ancora G, et al., Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation., The Journal of pediatrics, 2013, 163(3), 645-51
- da Silva P, et al., Use of fentanyl and midazolam in mechanically ventilated children--Does the method of infusion matter?, Journal of critical care, 2016, 32, 108-13
- Hameln Pharma GmbH., SmPC Fentanyl hameln 50 microgram/ml, oplossing voor injectie, (RVG 25458) 01-03-2024, www.geneesmiddelinformatiebank.nl
- Simion C, et al., Postoperative pain control for primary cleft lip repair in infants: is there an advantage in performing peripheral nerve blocks?, Paediatr Anaesth, 2008, 18(11), 1060-5
- 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
- NHS, How should medicines be dosed in children who are obese?, 2021
- Dewhirst E, et al., Chest wall rigidity in two infants after low-dose fentanyl administration, 2012, Contract No.:5, Report No.: 1535-1815 (Electronic)
- Völler S, et al., Rapidly maturing fentanyl clearance in preterm neonates., Arch Dis Child Fetal Neonatal Ed., 2019, 104(6), 598-603
- 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
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Changes
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