Post Operative AnalgesiaDICLOPOPNCT07646093
Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain in Children
A study testing Diclofenac Potassium Medicated Lollipop in people with Post Operative Analgesia and Tonsillectomy, run by Hospital Universitario de Caracas at 1 site in Venezuela.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Analgesia, Tonsillectomy, Pediatric Anesthesia
- What is being tested?
- Diclofenac Potassium Medicated Lollipop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteVenezuela
- Study dates
- 1 May 2025to 31 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Diclofenac Potassium Medicated Lollipop
- Keywords
- diclofenac, medicated lollipop, drug delivery system, oral transmucosal delivery, pediatric formulation, pharmaceutical formulation, postoperative pain, tonsillectomy, pediatric anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Potassium Medicated LollipopDrug
Also called DICLOPOP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Diclofenac Potassium Medicated Lollipop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity assessed using a 10-point Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater postoperative pain intensity following administration of weight-adjusted diclofenac potassium medicated lollipops
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 May 2025
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Caracas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Alejandro Veraza Almeida, Hospital Universitario de Caracas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646093
- Sponsor's protocol ID
- DPML-2025-001
- Acronym
- DICLOPOP
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.