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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Miranda
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Caracas, Miranda, Venezuela, 1040
- Hospital Universitario de Caracas
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Postoperative Pain Intensity
Tijdsspanne: 24 hours post operative
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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
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24 hours post operative
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DPML-2025-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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