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Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain in Children
Sponsor: Hospital Universitario de Caracas
Summary
\*\*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.
Official title: Development and Preliminary Clinical Evaluation of a Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain Management in Paediatric Patients
Key Details
Gender
All
Age Range
4 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-05-01
Completion Date
2025-05-31
Last Updated
2026-06-16
Healthy Volunteers
Yes
Interventions
Diclofenac Potassium Medicated Lollipop
A weight-adjusted gelatin-based diclofenac potassium medicated lollipop formulated for paediatric postoperative analgesia. Three dosage strengths (15 mg, 20 mg, and 30 mg) were administered according to body weight every 8 hours during the first 24 postoperative hours following adenotonsillectomy.
Locations (1)
Hospital Universitario de Caracas
Caracas, Miranda, Venezuela