Clinical trial NCT06863714: Peritonsillar Bupivacaine Infiltration After Tonsillectomy In Children
Official title: Effect Of Peritonsillar Bupivacaine Infiltration on The Development of Postoperative Emergence Delirium After Tonsillectomy In Children: A Randomized, Double-Blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Delirium
Post Operative Pain
Keywords: Emergence Delirium
Tonsillectomy
Bupivacaine
Infiltration Analgesia
Postoperative Pain
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Emergence Delirium Scale
timeFrame: PAED scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.
Secondary outcomes:
measure: Face, Legs, Activity, Cry and Consolability
timeFrame: FLACC scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training Hospital
Study officials:
References: