Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain in Children

\*\*Brief Summary\*\* This study aimed to develop and conduct a preliminary clinical evaluation of a novel weight-adjusted gelatin-based diclofenac potassium medicated lollipop for the management of postoperative pain following adenotonsillectomy in children. The formulation was designed to improve analgesic adherence by providing a palatable and child-friendly dosage form suitable for oral transmucosal administration. Fifty paediatric patients aged 4 to 12 years undergoing elective adenotonsillectomy received one of three weight-adjusted diclofenac potassium lollipop doses (15 mg, 20 mg, or 30 mg) every 8 hours during the first 24 postoperative hours. The study assessed postoperative pain intensity, product acceptability, rescue analgesic use, and safety. In parallel, the formulation underwent pharmaceutical characterization, including physicochemical and microbiological quality evaluation.

Inclusion Criteria: * Children aged 4 to 12 years. * Scheduled for elective adenotonsillectomy under general anaesthesia. * American Society of Anesthesiologists (ASA) physical status I or II. * Ability to tolerate oral administration of the medicated lollipop after surgery. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Known hypersensitivity or contraindication to diclofenac or other non-steroidal anti-inflammatory drugs. * History of asthma precipitated by NSAIDs. * Active gastrointestinal ulcer disease or gastrointestinal bleeding. * Significant hepatic, renal, cardiovascular, or coagulation disorders. * Severe developmental delay or neurological conditions preventing reliable pain assessment. * Requirement for postoperative intensive care admission. * Refusal of participation by the patient or parent/legal guardian.