Safety and efficacy of pre-incisional peritonsillar lornoxicam in paediatric post-tonsillectomy pain: a prospective double-blind, placebo-controlled, split-body clinical study.

Abstract

To evaluate the risk of peri-operative bleeding and re-intervention with peritonsillar lornoxicam infiltration in paediatric tonsillectomy. Prospective, randomised, double-blinded, placebo-controlled, split-body study. University hospital. A total of 68 patients (7-15 years), ASA I-II, scheduled for tonsillectomy divided into two groups (n = 34) to receive bilateral peritonsillar saline infiltration (placebo group) or peritonsillar saline infiltration in one tonsil (placebo side) and 8 mg lornoxicam in the other tonsil (intervention side; study group). Drugs were administered after induction of anaesthesia and before start of surgery. Intra-operative and postoperative bleeding score, platelet aggregometry before and 30 min after study drug administration, the verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative and adverse effects were evaluated. The difference in bleeding score between groups did not reach our definition of statistical significance (P < 0.05). Platelet aggregometry tests did not change significantly with time between groups. Lower postoperative pain scores, longer time to first analgesic request (372.76 ± 82.15 versus 64.89 ± 25.76 min P < 0.001) and lower paracetamol consumption (421.76 ± 125.63 versus 690.29 ± 141.47 mg, P < 0.001) were recorded in study group compared with control group. No patient required hospital re-admission or re-operation because of postoperative tonsillar bed bleeding. The lack of significant complications suggests that pre-incisional peritonsillar lornoxicam followed by intravenous paracetamol rescue analgesia may be safe for tonsillectomy in children. To avoid conflict with intra-operative bleeding, postoperative infiltration of lornoxicam is recommended.