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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Miranda
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Caracas, Miranda, Venezuela, 1040
- Hospital Universitario de Caracas
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Intensity
Tidsramme: 24 hours post operative
|
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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DPML-2025-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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