PALMITOYLETHANOAMIDE ULTRAMICRONIZED IN PEDIATRIC PATIENTS AFTHER LIMB ELONGATION SURGERY

S. Kotzeva¹, A. Wolfler¹, L. Palomba², D. Innocenti² | ¹IRCCS Giannina Gaslini UOC Anesthesiology and acute and procedural pain therapy, Genoa; ²IRCCS Giannina Gaslini, Genoa

BACKGROUND
Limb elongations develop a severe postoperative pain with a significant negative impact on patient's quality of life and in paediatrics can lead to t psychological and emotional burdens for both the children and their families. In our Institution, a Transitional Acute Pain Service has been introduced as an interdisciplinary setting to manage pain in the perioperative continuum both in hospital and at home. For these patients as a standard care in the past we use oral opioids, NSAIDs and Paracetamol.The use of Palmitoylethanolamide (PEA) has been suggested to have useful analgesic properties and to be devoid of unwanted effects. It is emerging as a new therapeutic approach in pain and inflammatory conditions, and in pediatrics, there are studies published for treatment of abdominal pain in irritable bowel syndrome and migraine, but not yet for postoperative pain in children limb-lengthening procedures. Aim of this pilot study is to evaluate the efficacy of ultramicronized PEA (umPEA) in children after limb lengthening procedure, who need a pain therapy at home during limb elongation compared to an historical group of patients.
METHODS
The study included children who underwent limb legthening surgery. Hospital pain therapy after surgery was the same for patients receiving umPEA and the historical controls while home care was different. In the control group it consisted of NSAIDs, Delorazepam 0,03 mg/kg once per day and oxycodone 5 -10 mg based on weight and aged of the patient twice a day. The new protocol did not foresee the use of the opiate, but consisted of Paracetamol, NSAIDs, delorazepam and umPEA 500 mg once a day started on the 5th postoperative day with rescue dose of Tramadol. Patients were then followed up from one to three months to assess their trajectory of pain. We recorded need for opioid use or any modification of the oral pain therapy at home when patient experienced severe pain during elongation periods. Using direct interviews during follow-up visits or via telephone adverse events were recorded. Follow-up care allows for the recognition of patients with an abnormal or unexpected pain trajectory, so that additional interventions can be initiated promptly. Pain was assessed using numeric ranking scale at the 1st, 2nd and 3rd month during control visit. Data were compared with our historical group.
RESULTS
From 01/10/2025 to 30/05/2025 twelve patients have been enrolled in the study. Mean age was 13.5 years (range 10-17), mean weight 53 kg (range 40-60). Included in the study were five patients with achondroplasy, three with hemimely, one heterometry, one with exostosis disease, and two with complex limb anomalies of upper and lower extremities. The mean number of visits on site were 1 by month. One patient (8.3%) needed modification of the therapy with administration of potent opioids while in the control group (n = 30) all the patient received oxycodone. No side effects were observed due to umPEA administration. Local infection of the exit site of external fixations were recorded in two patients. These two also required rescue medications.
CONCLUSIONS
Our preliminary data showed that umPEA administered for three months seems to reduce pain intensity in pediatric patients after elongation surgery and reduce the need of opioids for long period of time. Further clinical data and prospective RCT need to investigate the role of umPEA for postoperative chronic surgical pain in pediatrics.