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May 30, 2018

ESPA Statement for the safe use of tramadol

The ESPA Pain Committee published recently the “Postoperative pain management in children: Guidance from the pain committee of the European…

The ESPA Pain Committee published recently the “Postoperative pain management in children: Guidance from the pain committee of the European Society for Paediatric Anaesthesiology (ESPA Pain Management Ladder Initiative)” (1).  In this guidance we recommend the postoperative use of tramadol for certain indications in children. The ESPA Pain committee is also aware of recent publications concerning the use of tramadol in children. The Food and Drug Administration (FDA) issued new information restricting the use of codeine and tramadol in children in the USA (2). The ESPA Pain Management Ladder is a statement paper from the EUROPEAN Society of Pediatric Anesthesia, it is not really reasonable that we should take into account the local differences outside Europe. Furthermore the European Medicines Agency (EMA) restricts the use of tramadol for postoperative pain management in children with certain conditions such as OSAS and compromised respiratory function (3). The ESPA Pain management Ladder already includes the following warning: In patients with obstructive sleep apnea extra caution is warranted (avoid/minimize opioid dosage, enhance monitoring, longer hospital stay).

 

The ESPA Pain Committee is also aware of recent papers that clearly describe the possible dangers associated with the use of tramadol (4). Tramadol as any other potent drug has to be used with care and it is important to apply an individualized prescription of opioid drugs according to age, comorbidities (OSAS, renal function), body weight, racial origin and specific risk factors of the individual patient).  A risk-benefit analysis has always to be performed before administering any medication to children and adolescents. But we should not throw the baby out with the bath-water and stop providing adequate postoperative pain management for our patients. (5)  The ESPA Pain Management Ladder provides suggestions for the intra- and early postoperative pain management in the hospital setting where adequate monitoring should be applied. In the early postoperative period opioid drugs have to be titrated to effect to determine the patient tailored dosage for each child.  Adequate pain management is according to the Declaration of Montreal (September 2010) a Fundamental Right and it is our duty to provide this to all patients.

 

References:

  1.  Postoperative pain management in children: Guidance from the pain committee of the European Society for Paediatric Anaesthesiology (ESPA Pain Management Ladder Initiative) Vittinghoff M, Lönnqvist PA, Mossetti V, Heschl S, Simic D, Colovic V, Dmytriiev D, Hölzle M, Zielinska M, Kubica-Cielinska A, Lorraine-Lichtenstein E, Budić I, Karisik M, Maria BJ, Smedile F, Morton NS. Paediatr Anaesth. 2018 Apr 10. doi: 10.1111/pan.13373. [Epub ahead of print]
  2. FDA drug safety communication od tramadol: https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm
  3. EMA statement on tramadol: https://www.ema.europa.eu/docs/en_GB/document_library/Periodic_safety_update_single_assessment/2018/03/WC500245268.pdf
  4. Trends in Tramadol: Pharmacology, Metabolism, and Misuse. Miotto K, Cho AK, Khalil MA, Blanco K, Sasaki JD, Rawson R. Anesth Analg. 2017 Jan;124(1):44-51.
  5. Tramadol: keep calm and carry on. Anderson BJ1, Thomas J2, Ottaway K1, Chalkiadis GA3.  Paediatr Anaesth. 2017 Aug;27(8):785-788. doi: 10.1111/pan.13190.