NCT06731556

Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases

Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol for Pain Relief After Pediatric Tonsillectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tonsil Disease
• Pain Management
• Intranasal Drug Administration

Interventions

Type	Name	Description
DRUG	Intravenous paracetamol	Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.
DRUG	Intranasal Paracetamol	Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.
DRUG	Intranasal Diclofenac Sodium	Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.
DRUG	Intranasal Ibuprofen	Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.

Timeline

• Start date: 2024-12-15
• Primary completion: 2024-12-30
• Completion: 2025-01-15
• First posted: 2024-12-12
• Last updated: 2025-02-28

Locations

1 site across 1 country: Turkey (Türkiye)