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

Interactions
PK
Renal impairment
References

Piritramide

Generic name
Piritramide
Brand name
ATC Code
N02AC03

Pharmacokinetics in children

There is a general lack of published pharmacokinetic data on the use of piritramide in children. Compared to infants, young children, and adults, neonates showed a higher initial concentration and a clearly prolonged elimination. Since infants and young children's elimination rates are higher than those of adults, therefore the duration of effects will be shortened (Muller 2006)).

The following pharmacokinetic parameters were found in children (n=39) in the intensive care unit (ICU) setting (Muller 2006):

parameter Median ± SE (Range) Population
neonates
(N = 8)		 infants group 1
(N = 7)		 infants group 2
(N = 14)		 children
(N = 10)
age 10,6 ± 10,7 days
(1 – 27 days)		 11,4 ± 4,4 weeks
(5,4 – 16,9 weeks)		 9,0 ± 2,3 months
(5,2 – 12,2 months)		 2,4 ± 0,9 years
(1,61 – 4,02 years)
Cmax (µg/l) 79 ± 240
(5 – 723)		 36 ± 367
(6 – 855)		 12 ± 81
(3 – 315)		 16 ± 9
(9 – 35)
T½β (min) 701,5 ± 720
(88 – 1950)		 157 ± 102
(106 – 394)		 160 ± 68
(114 – 335)		 165 ± 143
(101 – 512)
Clt (ml/kg/min) 5,0 ± 4,8
(0,7 – 15,6)		 9,8 ± 12,3
(1,3 – 32,1)		 26,7 ± 42,7
(2,8 – 172,1)		 24,0 ± 11,6
(5,7 – 41,1)
Vdss (l/kg) 1,96 ± 4,93 (0,07 – 13,9) 1,70 ± 2,5
(0,12 – 5,78)		 6,95 ± 5,15
(0,58 – 17,02)		 6,70 ± 2,15
(1,20 – 8,10)

 

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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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General Dose Info

Due to lack of data on piritramide, the dose is extrapolated from morphine. Piritramid is less potent than morphine. In clinical practice equal doses for morphine and piritramide are used.

 

Dosages

Severe pain
  • Intramuscular
    • ≥ 5 years
      • 0.05 - 0.2 mg/kg/dose, as required, max. 4x daily.
  • Subcutaneous
    • 1 month up to 3 years

      • VENTILATED PATIENTS

        Starting dose: 100 microgram/kg/dose, bolus
        Maintenance dose, continuous infusion:
        4-9 kg: 10-15 microgram/kg/hour, titrated up to 40 microgram/kg/hour
        10-15kg: 15-20 microgram/kg/hour, titrated up to 40 microgram/kg/hour
        In case insufficient pain control, repeat bolus of 50 – 100 microgram/kg/dose and increase continuous infusion dose 

        NON-VENTILATED PATIENTS

        Starting dose: 
        PICU: 15 microgram/kg/dose, bolus. Repeat 3 times if needed. In case of insufficient pain control after repeating, start with continuous infusion.
        PACU: 10-50 microgram/kg/dose (repeat dose if necessary) under continuous monitoring until sufficient pain control is reached, then continuous infusion can be started. 
        Maintenance dose, continuous infusion:
        4-9 kg: 10-15 microgram/kg/hour, titrated up to 40 microgram/kg/hour
        10-15kg: 15-20 microgram/kg/hour, titrated up to 40 microgram/kg/hour

    • 3 years up to 18 years and ≥ 15 kg

      • VENTILATED PATIENTS

        Starting dose: 100 microgram/kg/dose, bolus
        Maintenance dose, continuous infusion:10-40 microgram/kg/hour
        In case insufficient pain control, repeat bolus of 50 – 100 microgram/kg/dose and increase continuous infusion dose 

        NON-VENTILATED PATIENTS

        Starting dose: 
        PICU: 15 microgram/kg/dose, bolus. Repeat 3 times if needed. In case of insufficient pain control after repeating, start with continuous infusion.
        PACU: 10-50 microgram/kg/dose (repeat dose if necessary) under continuous monitoring until sufficient pain control is reached, then continuous infusion can be started. 
        Maintenance dose, continuous infusion: 10-40 microgram/kg/hour 

  • Intravenous
    • 1 month up to 3 years

      • VENTILATED PATIENTS

        Starting dose: 100 microgram/kg/dose, bolus
        Maintenance dose, continuous infusion:
        4-9 kg: 10-15 microgram/kg/hour, titrated up to 40 microgram/kg/hour
        10-15kg: 15-20 microgram/kg/hour, titrated up to 40 microgram/kg/hour
        In case insufficient pain control, repeat bolus of 50 – 100 microgram/kg/dose and increase continuous infusion dose 

        NON-VENTILATED PATIENTS

        Starting dose: 
        PICU: 15 microgram/kg/dose, bolus. Repeat 3 times if needed. In case of insufficient pain control after repeating, start with continuous infusion.
        PACU: 10-50 microgram/kg/dose (repeat dose if necessary) under continuous monitoring until sufficient pain control is reached, then continuous infusion can be started. 
        Maintenance dose, continuous infusion:
        4-9 kg: 10-15 microgram/kg/hour, titrated up to 40 microgram/kg/hour
        10-15kg: 15-20 microgram/kg/hour, titrated up to 40 microgram/kg/hour

    • 3 years up to 18 years and ≥ 15 kg

      • VENTILATED PATIENTS

        Starting dose: 100 microgram/kg/dose, bolus
        Maintenance dose, continuous infusion:10-40 microgram/kg/hour
        In case insufficient pain control, repeat bolus of 50 – 100 microgram/kg/dose and increase continuous infusion dose 

        NON-VENTILATED PATIENTS

        Starting dose: 
        PICU: 15 microgram/kg/dose, bolus. Repeat 3 times if needed. In case of insufficient pain control after repeating, start with continuous infusion.
        PACU: 10-50 microgram/kg/dose (repeat dose if necessary) under continuous monitoring until sufficient pain control is reached, then continuous infusion can be started. 
        Maintenance dose, continuous infusion: 10-40 microgram/kg/hour 
Severe pain: administration via PCA pump
  • Subcutaneous
    • 5 years up to 18 years

      • BOLUS: 15-20 microgram/kg, lockout interval 15-30 minutes,
        Background infusion (CONTINUOUS INFUSION): 0 - 15 microgram/kg/hour, max. 100 microgram/kg/hour

  • Intravenous
    • 5 years up to 18 years

      • BOLUS: 15-20 microgram/kg, lockout interval 10 minutes,
        Background infusion (CONTINUOUS INFUSION) 0 - 15 microgram/kg/hour, max. 100 microgram/kg/hour
CAUTION:
  • Route of administration not applicable
    • 0 years up to 18 years

      • Due to lack of data on piritramide, the dose is extrapolated from morphine. Piritramid is less potent than morphine. In clinical practice equal doses for morphine and piritramide are used.

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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

Spontaneously breathing neonates in particular may be at risk of respiratory depression because of prolonged elimination half-life and decreased clearance in this age group. [SmPC Dipidolor, Muller 2006]

 

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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

It may take up to 24 hours for the patient to benefit from the full analgesic effect of the given dose of Dipidolor. Increasing the dose of piritramide should be done cautiously to avoid accumulation of piritramide. This could, in fact, increase the risk of respiratory depression (Huenseler 2008; SmPC ).

When postoperative respiratory depression occurs, naloxone IV can be administrated (see naloxone  for dose recommendations). 

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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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Natural opium alkaloids
N02AA03
N02AA01
N02AA05
N02AA59
Phenylpiperidine derivatives
N02AB03
N02AB03
N02AB02
Diphenylpropylamine derivatives
N02AC06
Oripavine derivatives
N02AE01
Morphinan derivatives
N02AF02
Other opioids
N02AX06
N02AX01
N02AX02
Opioids in combination with non-opioid analgesics
N02AJ13

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References

  1. Piramal Critical Care B.V., SmPC Dipidolor (RVG 09129) 23-03-2021, www.geneesmiddeleninformatiebank.nl
  2. Janssen-Cilag NV, SmPC Dipidolor (BE119402) 30-03-2017, http://bijsluiters.fagg-afmps.be
  3. Association of Paediatric Anaesthetists of Great, B. and Ireland., Good practice in postoperative and procedural pain management, 2nd edition., Paediatr Anaesth, 2012, 22 Suppl 1, 1-79
  4. Huenseler C, et al., Prospective evaluation of the pharmacodynamics of piritramide in neonates and infants, Eur J Pediatr, 2008, 167(8), 867-72
  5. Müller C, et al., Pharmacokinetics of piritramide in newborns, infants and young children in intensive care units, Eur J Pediatr, 2006, 165(4), 229-39
  6. Krekels, E.H., et al., Evidence-based morphine dosing for postoperative neonates and infants., Clin Pharmacokinet, 2014, 53(6), 553-63
  7. Friedrichsdorf, S.J. and T.I. Kang,, The management of pain in children with life-limiting illnesses, Pediatr Clin North Am, 2007, 54(5), 645-72
  8. Experts opinion Editorial Board Kinderformularium NL, Meeting 10-03-2023
  9. Knibbe, C.A., et al;, Morphine glucuronidation in preterm neonates, infants and children younger than 3 years, Clin Pharmacokinet., 2009, 48(6), 371-85
  10. Berde, C.B. and N.F. Sethna,, Analgesics for the treatment of pain in children, N Engl J Med, 2002, 47(14), 1094-103
  11. Karl, H.W., et al, Controlled trial of morphine vs hydromorphone for patient-controlled analgesia in children with postoperative pain, Pain Med, 2012, 13(12), 1658-9
  12. Peters, J.W., et al.,, Patient controlled analgesia in children and adolescents: a randomized controlled trial., Paediatr Anaesth, 1999, 9(3), 235-41
  13. Goulooze, S.C., et al., Quantifying the Pharmacodynamics of Morphine in the Treatment of Postoperative Pain in Preverbal Children., J Clin Pharmacol, 2022, 62(1), 99-109
  14. Ceelie, I., et al., Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial., JAMA, 2013, 309(2), 49-54
  15. van Dijk, M., et al., Efficacy of continuous versus intermittent morphine administration after major surgery in 0-3-year-old infants; a double-blind randomized controlled trial, Pain, 2002, 98(3), 305-313
  16. Lynn, A.M., et al., Intravenous morphine in postoperative infants: intermittent bolus dosing versus targeted continuous infusions., Pain, 2000, 8(1), 89-95
  17. Bouwmeester, N.J., et al., Developmental pharmacokinetics of morphine and its metabolites in neonates, infants and young children., Br J Anaesth, 2004, 92(2), 208-17
  18. Duedahl, T.H. and E.H. Hansen., A qualitative systematic review of morphine treatment in children with postoperative pain, Paediatr Anaesth, 2007, 17(8), 756-74
  19. Doyle, E., et al, Comparison of patient-controlled analgesia in children by i.v. and s.c. routes of administration, Br J Anaesth, 1994, 72(5), 533-6
  20. McNeely, J.K. and N.C. Trentadue., Comparison of patient-controlled analgesia with and without nighttime morphine infusion following lower extremity surgery in children., J Pain Symptom Manage, 1997, 15(5), 268-73
  21. Walker, S.M., et al., Intravenous opioids for chemotherapy-induced severe mucositis pain in children: Systematic review and single-center case series of management with patient- or nurse-controlled analgesia (PCA/NCA)., Paediatr Anaesth, 2022, 32(1), 17-34
  22. Berde, C.B., et al.,, Patient-controlled analgesia in children and adolescents: a randomized, prospective comparison with intramuscular administration of morphine for postoperative analgesia., J Pediatr,, 1991, 118(3), 460-6
  23. Doyle, E., Iet al, Patient-controlled analgesia with low dose background infusions after lower abdominal surgery in children, Br J Anaesth, 1993, 71(6), 818-22
  24. Ozalevli, M., et al., Comparison of morphine and tramadol by patient-controlled analgesia for postoperative analgesia after tonsillectomy in children, Paediatr Anaesth, 2005, 15(11), 979-84

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