Peritonsillar Bupivacaine Infiltration After Tonsillectomy In Children

NCT06863714 | Completed

• 1 other identifier: turk-24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of peritonsillar bupivacaine infiltration on the development of postoperative delirium in pediatric patients undergoing tonsillectomy or adenotonsillectomy.

Conditions

Post Operative Delirium; Post Operative Pain

Keywords

Emergence Delirium; Tonsillectomy; Bupivacaine; Infiltration Analgesia; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pediatric Emergence Delirium Scale

  This scale system was created to evaluate the severity of delirium in children patients. In thİs scale system, patients are graduated between 0 and 20 points. A score of 0 reveals there are no delirium findings, and a score of 20 reveals there is a severe delirium.

  PAED scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.

Secondary Outcomes (1)

• Face, Legs, Activity, Cry and Consolability

  FLACC scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Peritonsillar injection was superficially administered to the superior and inferior peritonsillar regions in a volume of 2-5 ml. A 23 Gouge needle syringe was used for injection. A 0.5% Bupivacaine was administered at a dose of 1 mg/kg (maximum dose of 25 mg)

Drug: peritonsillar bupivacaine injection

group B

NO INTERVENTION

no intervetion

Interventions

peritonsillar bupivacaine injection DRUG

Peritonsillar injection was superficially administered to the superior and inferior peritonsillar regions in a volume of 2-5 ml. A 23 Gouge needle syringe was used for injection. A 0.5% Bupivacaine was administered at a dose of 1 mg/kg (maximum dose of 25 mg)

Group A

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patient have adenotonsillectomy
• age 3-7 years
• ASA-1

You may not qualify if:

• active infection,
• bleeding-coagulation disorder,
• neuropsychiatric disorder,
• bupivacaine hypersensitivity,
• postoperative delirium history,
• history of surgery for different reasons within 1 year,
• history of long-term hospitalization,
• chronic disease,
• chronic pain condition
• chronic analgesic use

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: September 10, 2023
• Primary Completion: September 10, 2024
• Study Completion: October 20, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)