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

NCT07646093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • Post Operative Analgesia
  • Tonsillectomy
  • Pediatric Anesthesia

Interventions

DRUG

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.

Sponsors & Collaborators

  • Hospital Universitario de Caracas

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Venezuela

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646093 on ClinicalTrials.gov