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

NCT06731556 | Completed Phase 3

• 1 other identifier: 20.08.2021-E.28962
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsil Disease; Pain Management; Intranasal Drug Administration

Keywords

Intranasal Spray; intranasal Analgesia; Diclofenac Sodium; Ibuprofen; Paracetamol; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).

Secondary Outcomes (1)

• 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).

Other Outcomes (1)

• 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).

Study Arms (4)

Intranasal Paracetamol

EXPERIMENTAL

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.

Drug: Intranasal Paracetamol

Intranasal Diclofenac Sodium

EXPERIMENTAL

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.

Drug: Intranasal Diclofenac Sodium

Intranasal Ibuprofen

EXPERIMENTAL

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.

Drug: Intranasal Ibuprofen

Intravenous Paracetamol

ACTIVE COMPARATOR

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.

Drug: Intravenous paracetamol

Interventions

Intravenous paracetamol DRUG

Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.

Also known as: intravenous paracetamol (Group 4)

Intravenous Paracetamol

Intranasal Paracetamol DRUG

Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.

Intranasal Paracetamol

Intranasal Diclofenac Sodium DRUG

Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.

Intranasal Diclofenac Sodium

Intranasal Ibuprofen DRUG

Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.

Intranasal Ibuprofen

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients who have undergone a tonsillectomy.

You may not qualify if:

• Chronic sinusitis
• Common cold or rhinitis
• Turbinate hypertrophy
• Nasal polyposis
• Deviated nasal septum
• Impaired mucociliary clearance
• Atrophic rhinitis

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Ramazan Bahadır KÜÇÜK

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized study

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 12, 2024
• Study Start: December 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 15, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Access Criteria: The period of completion of the study and data analysis 30 December 2024-15 January 2025

Locations

TU (1)