Tonsil Disease, Pain Management, Intranasal Drug Administration
Conditions
Keywords
Intranasal Spray, intranasal Analgesia, Diclofenac Sodium, Ibuprofen, Paracetamol, Tonsillectomy
Brief summary
This study aims to evaluate the efficacy and safety of intranasal Diclofenac Sodium, intranasal Ibuprofen, and intranasal Paracetamol for pain control following tonsillectomy in pediatric patients.
Detailed description
Postoperative pain management in pediatric tonsillectomy remains a challenge, with concerns about the safety and efficacy of available analgesic options. Intranasal administration of nonsteroidal anti-inflammatory drugs presents a promising alternative for effective pain relief with minimal side effects. This prospective, randomized study evaluated the efficacy and safety of intranasal diclofenac sodium, intranasal ibuprofen, and intranasal paracetamol compared to intravenous paracetamol in pediatric patients following tonsillectomy. Sixty patients, aged 2 to 14 years, were divided into four groups to receive either intranasal paracetamol (Group 1), intranasal diclofenac sodium (Group 2), intranasal ibuprofen (Group 3), or intravenous paracetamol (Group 4). Pain was assessed using the CHEOPS, VAS, and Wong-Baker modified VAS scoring systems at various postoperative time points. Statistical analysis was performed using the Kruskal-Wallis and Dunn's tests.
Interventions
Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.
DRUGIntranasal Paracetamol
Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.
DRUGIntranasal Diclofenac Sodium
Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.
DRUGIntranasal Ibuprofen
Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
prospective, randomized study
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
-Pediatric patients who have undergone a tonsillectomy.
Exclusion criteria
* Chronic sinusitis * Common cold or rhinitis * Turbinate hypertrophy * Nasal polyposis * Deviated nasal septum * Impaired mucociliary clearance * Atrophic rhinitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Hospital of Eastern Ontario Pain Scale measurements | Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery). | CHEOPS consists of a total of 6 categories of behaviour, with specific score ranges for each. The total score ranges from 6 to 16. A score of 16 means a lot of pain, while 4 means no pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VISUAL ANALOGUE Scale measurements | Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery). | The patient indicates the level of pain by marking it on a visual scale, with one end of the line labelled 'No Pain' (0) and the other end labelled 'Intolerable Pain' (10). 0: No pain at all. 1-3: Mild pain. 4-6: Moderate pain. 7-10: Severe pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker Facial Pain Scale (Modified VAS) measurements | Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery). | It is an adapted version for children. Pain is graded on the basis of different facial expressions (happy face → crying face). A happy face means no pain, while a crying face means a lot of pain. |
Countries
Turkey (Türkiye)
Outcome results
None listed