Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol for Pain Relief After Pediatric Tonsillectomy
Phase: PHASE3
Conditions: Tonsil Disease, Pain Management, Intranasal Drug Administration
Sponsor: Bezmialem Vakif University

Study Protocol 
 
Title: Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in 
Pediatric Tonsillectomy Cases 
Document Date: 11/12/2024 
NCT Number: NCT06731556 
Unique Protocol ID: 20.08.2021-E.28962 
Objective: This study aims to evaluate the efficacy and safety of intranasal diclofenac 
sodium, ibuprofen, and paracetamol for postoperative analgesia in pediatric tonsillectomy 
patients. 
Study Design: 
- Prospective, randomized study. 
- Participants: 60 children aged 2–14 years. 
- Groups: 
- Group 1: Intranasal paracetamol. 
- Group 2: Intranasal diclofenac sodium. 
- Group 3: Intranasal ibuprofen. 
- Group 4: Intravenous paracetamol. 
Outcome Measures: 
- Primary: Pain levels assessed via CHEOPS, VAS, and Wong-Baker modified VAS. 
- Secondary: Safety parameters and side effects. 
Ethical Approval: 
- Approved by the Clinical Research Ethics Committee of Bezmialem Vakıf University on 
20/08/2021, decision number 3/24. 
Procedures: 
The drugs were prepared at the Faculty of Pharmacy, Bezmialem Vakıf University. 

The patients were divided into four groups to control post-operative analgesia: Intranasal 
paracetamol (Group 1), Intranasal diclofenac sodium (Group 2), Intranasal ibuprofen (Group 3), 
and Intravenous paracetamol (Group 4). Patients with pathologies such as chronic sinusitis, cold, 
rhinitis, turbinate hypertrophy, nasal polyposis, deviated septum, impaired mucociliary clearance, 
and atrophic rhinitis were excluded. 
Pain levels were assessed using the Modified Children's Hospital of Eastern Ontario Pain 
Scale (CHEOPS) established by McGrath et al. . In this postoperative pain assessment, 
behavioral scoring (crying, facial expression, verbal complaints, body position, leg 
movements, and touching the wound) was evaluated by an experienced observer. The 
Wong-Baker modified VAS scoring system was used for children aged 4-8 years, and the 
VAS  scoring system was used for children aged 9-15 years .  Pain levels were recorded 
by an independent observer at 15, 30, 60, 120 minutes and  4, 6, 12 hours after the end of 
surgery. 
All patients underwent the same surgical procedure. Electrocardiography, noninvasive 
blood pressure and pulse oximetry were performed in all patients after admission to the 
operating room. For induction of general anesthesia, 1 mg/kg lidocaine, 1 µg/kg fentanyl, 
and 2-2.5 mg/kg propofol were administered. Patients were ventilated in volume control 
mode with FiO2: 0.5, tidal volume: 6-8 mL/kg, frequency: 15-22/min, and end-tidal 
carbon dioxide: 30-35 mmHg. Sevoflurane (1.5%-2%) in a 50%:50% medical air: oxygen 
mixture was used for anesthesia maintenance. 
Postoperative pain, sedation, and side effect measurements were recorded objectively by 
a blinded observer. 

Data Management: 
- Data collected by independent, blinded observers.