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NCT Number: NCT06731556

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

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.

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Key information

Conditions

Tonsil Disease Agnosia Intranasal Drug Administration Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ramazan Bahadır KÜÇÜK

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous paracetamol

Drug

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

Other names: intravenous paracetamol (Group 4)

Intranasal Paracetamol

Drug

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

Intranasal Diclofenac Sodium

Drug

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

Intranasal Ibuprofen

Drug

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

Primary outcomes

  1. Children's Hospital of Eastern Ontario Pain Scale measurements

    Time frame: 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 outcomes

  1. VISUAL ANALOGUE Scale measurements

    Time frame: 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.

Other outcomes

  1. Wong-Baker Facial Pain Scale (Modified VAS) measurements

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

    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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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