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.

NCT Number	NCT07646093
Lead Sponsor	Hospital Universitario de Caracas
Conditions	Post Operative Analgesia, Tonsillectomy, Pediatric Anesthesia
Enrollment	50 participants
Start Date	2025-05-01
Primary Completion	2025-05-31 (estimated)
Study Completion	2025-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-16