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

Interactions
PK
Renal impairment
References

Alfentanil

Generic name
Alfentanil
Brand name
ATC Code
N01AH02

Pharmacokinetics in children

There have been pharmacokinetic studies with small groups of neonates. The results vary greatly between the studies. There is also large inter-individual variability within the studies.

Age T1/2β (h) CL (ml/kg/min) Vdss (l/kg)
Premature neonates (25-40 GA): (0-28 Days) n=68: 0,7-8,8 0,9-8,4 0,3-1,2
Term neonates: (35-41 GA): (0-28 Days) n=18 4,1-5,5  1,7-3,2 0,5-0,8
Infants (28 Days up to 24 months): n=34 0,9-1,2  7,7-13,1 0,4-1,1
Children (2-12 Years): n=32 0,7-1,3 4,7-10,2 0,2-1,0
Adolescents (12-14 Years):, n=3 1,1-1,9 5,5-7,4 0,3-0,6

CL = plasma clearance, Vdss = volume of distribution at steady state, t 1/2β = half life in the elimination phase

Data for neonates, babies and children are given as a range of mean values.

Plasma protein binding is 75% in newborns and increases to 85 % in children.

Alfentanil is metabolized by CYP3A4. The CYP-3A4 activity at birth is low and increases to 30-40% of adult level after 1 month, 45% after 6 months, 80% after 1 year and 100% after 6 years.  (SmPC Rapifen 11/2022)

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

No information is present at this moment.

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Available formulations

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Dosages

Opioid analgesia (combined with a hypnotic) for induction of anesthesia; Analgesia (combined with general anesthesia) for short and long term procedures
  • Intravenous
    • 1 month up to 18 years
      • Initial dose: 10 - 20 microg./kg/dose slow bolus with an additional 5-10microg/kg at appropriate intervals.
      • Maintenance dose: for analgesia during surgery 0.5 - 2 microg./kg/minute, continuous infusion. Titrate to effect.
        • In combination with iv anesthetics: approximately 1 mcg/kg/min
        • Due to age related PK differences infants (28 days-2 years) may need HIGHER doses.
        • Even for short procedures, respiratory support devices should be available for use in spontaneously breathing children of all ages.  
    • 1 month up to 18 years
      [3] [4] [5] [7] [8] [9] [12] [13] [14] [18]
      • Initial dose: 10 - 20 microg./kg/dose slow bolus with an additional 5-10microg/kg at appropriate intervals.
      • Maintenance dose: for analgesia during surgery 0.5 - 2 microg./kg/minute, continuous infusion. Titrate to effect.
        • In combination with iv anesthetics: approximately 1 mcg/kg/min
        • Due to age related PK differences infants (28 days-2 years) may need HIGHER doses.
        • Even for short procedures, respiratory support devices should be available for use in spontaneously breathing children of all ages.  

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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

The side effects are similar in their nature and severity like in adults.

In neonates, mild to moderate muscle rigidity has been observed in a small number of neonates in clinical studies.  Severe rigidity and twitching occur less frequently and particularly with high doses of alfentanil or a rapid i.v. injection rate, temporalily accompanied by impaired breathing (SmPC Rapifen 11/2022)


 

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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

Caution is needed in cases of increased intracranial pressure and myasthenic syndrome. For children, there should always be supportive breathing equipment available; consider a muscle relaxant for neonates and young infants. Monitor all children until sufficient time has elapsed after the treatment. (SmPC Rapifen)

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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
N01AH01
N01AH06
N01AH03
Other general anesthetics
N01AX01
N01AX14
N01AX07
N01AX10

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References

  1. Antmen B, et al, Safe and effective sedation and analgesia for bone marrow aspiration procedures in children with alfentanil, remifentanil and combinations with midazolam. , Paediatr Anaesth., 2005, Mar;15(3), 214-9
  2. Begec Z, et al, Ketamine or alfentanil administration prior to propofol anaesthesia: the effects on ProSeal laryngeal mask airway insertion conditions and haemodynamic changes in children, Anaesthesia, 2009, Mar;64(3), 282-6
  3. Davis PJ, et al, Continuous alfentanil infusion in pediatric patients undergoing general anesthesia for complete oral restoration, J Clin Anesth, 1991, Mar-Apr;3(2), 125-30
  4. Davis PJ, et al, A randomized multicenter study of remifentanil compared with alfentanil, isoflurane, or propofol in anesthetized pediatric patients undergoing elective strabismus surgery, Anesth Analg, 1997, May;84(5), 982-9
  5. Ganidagli S, et al, Remifentanil vs alfentanil in the total intravenous anaesthesia for paediatric abdominal surgery, Paediatr Anaesth, 2003, Oct;13(8), 695-700
  6. Killian A, et al, Influence of gestational age on pharmacokinetics of alfentanil in neonates, Dev Pharmacol Ther, 1990, 15(2), 82-5
  7. Kim JY, et al, Post-induction alfentanil reduces sevoflurane-associated emergence agitation in children undergoing an adenotonsillectomy, Acta Anaesthesiol Scand, 2009, May;53(5), 678-81
  8. Kim JY, et al, Prevention of rocuronium-induced withdrawal movement in children: a comparison of remifentanil with alfentanil., Paediatr Anaesth., 2008, Mar;18(3), 245-50
  9. Kwak HJ, et al, Optimal bolus dose of alfentanil for successful tracheal intubation during sevoflurane induction with and without nitrous oxide in children, Br J Anaesth, 2010, May;104(5), 628-32
  10. Kwak HJ, et al, Prevention of propofol-induced pain in children: combination of alfentanil and lidocaine vs alfentanil or lidocaine alone, Br J Anaesth, 2009, Sep;103(3), 410-2
  11. Marlow N, et al, Alfentanil pharmacokinetics in preterm infants, Arch Dis Child, 1990, Apr;65(4 Spec No), 349-51
  12. McConaghy P, et al, Assessment of intubating conditions in children after induction with propofol and varying doses of alfentanil, Br J Anaesth, 1994, Nov;73(5), 596-9
  13. Mulroy JJ, Jr., et al, Safety and efficacy of alfentanil and halothane in paediatric surgical patients, Can J Anaesth, 1991, May;38(4 Pt 1), 445-9
  14. Oh AY, et al, Prevention of withdrawal movement associated with injection of rocuronium in children: comparison of remifentanil, alfentanil and fentanyl, Acta Anaesthesiol Scand, 2007, Oct;51(9), 1190-3
  15. Rahman Al-Refai A, et al, Prevention of pain on injection of propofol: a comparison of remifentanil with alfentanil in children, Minerva Anestesiol, 2007, Apr;73(4), 219-23
  16. Saarenmaa E, et al, Alfentanil as procedural pain relief in newborn infants, Arch Dis Child Fetal Neonatal Ed, 1996, Sep;75(2), F103-7
  17. Wiest DB, et al, The disposition of alfentanil in neonates with respiratory distress, Pharmacotherapy, 1991, 11(4), 308-11
  18. Piramal Critical Care Deutschland GmbH, SmPC RAPIFEN, 0,5 mg/mL Injektionslösung (2888.00.00), 11/2022
  19. Antmen B, et al, Safe and effective sedation and analgesia for bone marrow aspiration procedures in children with alfentanil, remifentanil and combinations with midazolam., Paediatr Anaesth., 2005, Mar;15(3), 214-9

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Changes

Changes