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

NCT07646093 | Completed

• 1 other identifier: DPML-2025-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diclofenac; medicated lollipop; drug delivery system; oral transmucosal delivery; pediatric formulation; pharmaceutical formulation; postoperative pain; tonsillectomy; pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diclofenac Potassium Medicated Lollipop

EXPERIMENTAL

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

Interventions

Diclofenac Potassium Medicated Lollipop DRUG

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.

Also known as: DICLOPOP

Diclofenac Potassium Medicated Lollipop

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Caracas: lead

Study Sites (1)

Hospital Universitario de Caracas

Caracas, Miranda, 1040, Venezuela

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Joseph Alejandro Veraza Almeida

Model Details: Single-arm pilot interventional study in which all enrolled paediatric participants received a weight-adjusted diclofenac potassium medicated lollipop for postoperative pain management following adenotonsillectomy.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: May 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)