Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06731556
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases
Sponsor:
Bezmialem Vakif University
Organization:
Study Overview
Official Title:
Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol for Pain Relief After Pediatric Tonsillectomy
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: