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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06863714
Enrollment
80
Registered
2025-03-07
Start date
2023-09-10
Completion date
2024-10-20
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Delirium, Post Operative Pain

Keywords

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

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.

Interventions

DRUGperitonsillar 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)

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pediatric Emergence Delirium ScalePAED scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.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.

Secondary

MeasureTime frameDescription
Face, Legs, Activity, Cry and ConsolabilityFLACC scores were measured at the beginning, 5th, 10th, 20th, 30th and 60th minutes in the postoperative recovery unit.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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026