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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.
Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.
Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.
Ramazan Bahadır KÜÇÜK
Istanbul, Turkey (Türkiye)
Children's Hospital of Eastern Ontario Pain Scale measurements
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.
Time frame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
VISUAL ANALOGUE Scale measurements
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.
Time frame: Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).
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Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.