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

Phase 3

Completed

• Conditions: Tonsil Disease; Pain Management; Intranasal Drug Administration
• Interventions: Drug: Intranasal Paracetamol; Drug: Intranasal Ibuprofen; Drug: Intranasal Diclofenac Sodium; Drug: Intravenous paracetamol

• Registration Number: NCT06731556
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Study Start: 2024-12-15
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Paracetamol	Intranasal Paracetamol	Participants in this arm received intranasal paracetamol (1.25 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.
Intranasal Ibuprofen	Intranasal Ibuprofen	Participants in this arm received intranasal ibuprofen (0.375 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.
Intranasal Diclofenac Sodium	Intranasal Diclofenac Sodium	Participants in this arm received intranasal diclofenac sodium (0.0625 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.
Intravenous Paracetamol	Intravenous paracetamol	Participants in this arm received intravenous paracetamol (20 mg/kg/day, twice daily) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ramazan Bahadır KÜÇÜK; 🇹🇷 Istanbul, Turkey