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

NCT06731556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-28

No results posted yet for this study

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

Interventions

DRUG

Intravenous paracetamol

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

DRUG

Intranasal Paracetamol

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

DRUG

Intranasal Diclofenac Sodium

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

DRUG

Intranasal Ibuprofen

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

Sponsors & Collaborators

  • Bezmialem Vakif University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2024-12-30
Completion
2025-01-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06731556 on ClinicalTrials.gov