Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain in Children (NCT07646093) | Clinical Trial Compass
CompletedNot Applicable
Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain in Children
Venezuela50 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.