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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Tonsil Disease; Intranasal Drug Administration
• Intervention / Treatment: Drug: Intranasal Paracetamol; Drug: Intranasal Diclofenac Sodium; Drug: Intranasal Ibuprofen; Drug: Intravenous paracetamol

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Ramazan Bahadır KÜÇÜK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Intranasal Paracetamol; Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.
Experimental: 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.	Drug: Intranasal Diclofenac Sodium; Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.
Experimental: 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.	Drug: Intranasal Ibuprofen; Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.
Active Comparator: 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.	Drug: Intravenous paracetamol; Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.; Other Names: intravenous paracetamol (Group 4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wong-Baker Facial Pain Scale (Modified VAS) measurements	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.	Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Tonsillectomy; Ibuprofen; Paracetamol; Diclofenac Sodium; Intranasal Spray; intranasal Analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Acetaminophen; Diclofenac; Ibuprofen
• Other Study ID Numbers: 20.08.2021-E.28962

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: I plan to share the excel file where the results are collected and made understandable
• IPD Sharing Access Criteria: The period of completion of the study and data analysis 30 December 2024-15 January 2025
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No