Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases
NCT ID: NCT06731556
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2024-12-15
2025-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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 Paracetamol
Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.
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.
Intranasal Diclofenac Sodium
Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.
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 Ibuprofen
Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.
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.
Intravenous paracetamol
Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.
Interventions
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Intravenous paracetamol
Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.
Intranasal Paracetamol
Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.
Intranasal Diclofenac Sodium
Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.
Intranasal Ibuprofen
Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Common cold or rhinitis
* Turbinate hypertrophy
* Nasal polyposis
* Deviated nasal septum
* Impaired mucociliary clearance
* Atrophic rhinitis
3 Years
18 Years
ALL
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Locations
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Ramazan Bahadır KÜÇÜK
Istanbul, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20.08.2021-E.28962
Identifier Type: -
Identifier Source: org_study_id
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