Pediatric Anesthesia, Post Operative Analgesia, Tonsillectomy
Conditions
Keywords
diclofenac, medicated lollipop, drug delivery system, oral transmucosal delivery, pediatric formulation, pharmaceutical formulation, postoperative pain, tonsillectomy, pediatric anesthesia
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.
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.
Interventions
DRUGDiclofenac Potassium Medicated Lollipop
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.
Sponsors
Hospital Universitario de Caracas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 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 |
Countries
Venezuela
Outcome results
None listed