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NCT Number: NCT06863714

Peritonsillar Bupivacaine Infiltration After Tonsillectomy In Children

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

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Key information

Conditions

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

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sisli Hamidiye Etfal Training Hospital

Istanbul, 34371, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Pediatric Emergence Delirium Scale

    Time frame: PAED 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 outcomes

  1. Face, Legs, Activity, Cry and Consolability

    Time frame: FLACC 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.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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