Peritonsillar Bupivacaine Infiltration After Tonsillectomy In Children

Effect Of Peritonsillar Bupivacaine Infiltration on The Development of Postoperative Emergence Delirium After Tonsillectomy In Children: A Randomized, Double-Blind, Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; Post Operative Delirium
• Intervention / Treatment: Drug: peritonsillar bupivacaine injection

Detailed Description

Postoperative emergence delirium (ED) is an important clinical condition characterized by crying, irritability and severe restlessness in subjects recovering from anesthesia. ED is more common in children than in adults. Among the types of surgery, the ED is common in ENT surgery in which the prevalence was reported between 13%-26%. The adenotonsillectomy, which is a common ENT procedure carry a high risk for development of ED.

The ED can cause the child recovering from anesthesia to harm himself/herself and the surgical site and may cause parents to question the quality of anesthesia. It is associated with postoperative increased morbidity. Several anesthetic strategies exists (intranasal premedication, deep versus awake removal of the laryngeal mask, different intravenous anesthetic combinations) in the literature in order to prevent delirium. Local anesthetic application as xylocaine was shown to reduce the postoperative pain and ED. In addition it is generally accepted that that postoperative ED can be reduced with good analgesia.

Local infiltration of peritonsillar fossa with various local anesthetics, steroids etc. is an established technique for relieving the postoperative pain. Bupivacaine as a long-acting local anesthetic is widely used for local infiltration anesthesia. It is a safe technique and several comparative studies exists in the literature on efficacy. A few number of studies exists that evaluates the relationship between effective pain control and postoperative ED development in children with regional anesthesia applications. However, in English literature we could not find a study on the effect of local infiltration of peritonsillar fossa on development of ED in subjects who underwent tonsillectomy/adenotonsillectomy operations.

The aim of this study is to evaluate the effect of peritonsillar bupivacaine infiltration on the development of postoperative delirium in pediatric patients undergoing tonsillectomy/adenotonsillectomy.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34371
    • Sisli Hamidiye Etfal Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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; 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)
No Intervention: group B; no intervetion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Face, Legs, Activity, Cry and Consolability	The Face, Legs, Activity, Cry and Consolability score is a scoring system created to evaluate the severity of pain in children in the postoperative period. The lowest score of 0 represents no pain, while a score of 10 indicates high pain severity.	FLACC scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): October 20, 2024

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Bupivacaine; Tonsillectomy; Emergence Delirium; Infiltration Analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Pain, Postoperative; Delirium; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: turk-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No