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

Development and Preliminary Clinical Evaluation of a Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain Management in Paediatric Patients

**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.

Study Overview

• Status: Completed
• Conditions: Pediatric Anesthesia; Tonsillectomy; Post Operative Analgesia
• Intervention / Treatment: Drug: Diclofenac Potassium Medicated Lollipop

Detailed Description

This prospective single-arm pilot study evaluated a newly developed gelatin-based diclofenac potassium medicated lollipop intended for postoperative pain management after paediatric adenotonsillectomy. The pharmaceutical formulation was optimized through iterative development and characterized by physicochemical testing, content uniformity analysis, and microbiological quality assessment according to pharmacopeial standards.

Children aged 4 to 12 years undergoing elective adenotonsillectomy received weight-adjusted diclofenac potassium lollipops (15 mg, 20 mg, or 30 mg) administered every 8 hours during the first 24 postoperative hours. Pain intensity was assessed before and after each dose using age-appropriate validated pain scales. Secondary evaluations included product acceptability, requirement for rescue analgesia, and occurrence of adverse events.

The study was designed as an exploratory pilot investigation to assess the feasibility, pharmaceutical performance, preliminary clinical effectiveness, and safety of this novel paediatric drug-delivery platform, providing the basis for future randomized controlled trials and pharmacokinetic evaluation.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Venezuela
  • Miranda
    • Caracas, Miranda, Venezuela, 1040
      • Hospital Universitario de Caracas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Potassium Medicated Lollipop; Participants received a weight-adjusted diclofenac potassium medicated lollipop (15 mg, 20 mg, or 30 mg according to body weight) every 8 hours during the first 24 postoperative hours following adenotonsillectomy for postoperative pain management.	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.; Other Names: DICLOPOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity	Postoperative pain intensity assessed using the Visual Analogue Scale (VAS) following administration of weight-adjusted diclofenac potassium medicated lollipops.	24 hours post operative

Collaborators and Investigators

• Sponsor: Hospital Universitario de Caracas

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: postoperative pain; tonsillectomy; pediatric anesthesia; diclofenac; drug delivery system; pediatric formulation; medicated lollipop; oral transmucosal delivery; pharmaceutical formulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: DPML-2025-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared because the study involves paediatric participants and contains potentially identifiable clinical information. Data may be made available upon reasonable request to the corresponding author, subject to institutional approval and applicable ethical and privacy regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No