RESUMEN
BACKGROUND: Tonsillectomy is one of the most common surgical procedures performed in children as a treatment for obstructive sleep apnea due to tonsil hypertrophy or highly recurrent tonsillitis. Odynophagia, associated with food refusal for the first few days, is a common post-operative complaint. Available drugs for pain management, while efficacious, present some drawbacks, and a novel strategy would be welcome. Photobiomodulation (PBMT), in this context, can represent a possible choice, together with pharmacological therapy. The aim of this study was to evaluate PBMT effects compared to standard pain therapy on nociceptive sensation at different time points and administration of painkiller. METHODS: A registered, controlled, randomized, double-blind clinical trial was performed. Twenty-two patients were recruited and divided into laser-treated (T) or untreated (UT) groups, based on random assignment. In T group, immediately after tonsillectomy, performed with cold dissection technique, laser light was applied to the surgery site (using a Cube 4 from Eltech K-Laser s.r.l., Treviso, Italy), and then hemostasis was performed using bismuth subgallate paste. In C group, the same procedure was performed, except that laser light was switched off. The primary outcome was the difference in pain scores between subject receiving photobiomodulation (PBMT) and subjects receiving standard care after 24 h; the secondary outcomes were pain scores at awakening and at 48 h together with distress (delirium) at awakening. RESULTS: Two patients from the T group experienced a post-surgery bleeding, and one of them required revision of the hemostasis under general anesthesia. A preliminary analysis of pain sensation reported by the patients or caregivers did not show differences between treated and untreated subjects. CONCLUSION: These data suggest that PBMT could increase post-surgical bleeding.