Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia

NCT07604337 | Not Yet Recruiting

• 1 other identifier: PEDGA-LA-2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether pre-emptive local anesthesia improves early recovery after ambulatory pediatric dental general anesthesia. Children aged 7-12 years scheduled for dental treatment under general anesthesia will be randomly assigned to receive either pre-emptive local anesthesia or no local anesthesia. Emergence behavior, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal emergence behavior score during the first 30 minutes in the post-anesthesia care unit.

Conditions

Emergence Delirium; Pediatric Dental General Anesthesia; Postoperative Recovery

Keywords

Pre-emptive local anesthesia; Pediatric anesthesia; Dental anesthesia; Emergence behavior; QoR-15 Pictorial; Ambulatory surgery

Outcome Measures

Primary Outcomes (1)

• Emergence Behavior Score During the First 30 Minutes in the Post-Anesthesia Care Unit

  Emergence behavior will be assessed using a PAED-derived 3-item emergence behavior assessment including eye contact, purposeful behavior, and awareness of surroundings. Each item is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate greater emergence behavior disturbance. Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1.

  PACU minutes 0, 5, 10, 15, and 30

Secondary Outcomes (2)

• Postoperative Pain Score

  PACU minutes 0, 5, 10, 15, and 30

• Recovery Quality Before Discharge

  Before discharge on day of surgery

Study Arms (2)

Pre-emptive Local Anesthesia

EXPERIMENTAL

Children randomized to this group will receive pre-emptive local anesthesia administered by the pediatric dentist before the dental procedure under general anesthesia.

Procedure: Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, do; Procedure: Pre-emptive Local Anesthesia; Drug: Articaine Hydrochloride With Epinephrine

No Local Anesthesia

NO INTERVENTION

Children randomized to this group will undergo dental treatment under general anesthesia without routine pre-emptive local anesthesia. Rescue analgesia or additional local anesthesia may be administered if clinically required and will be recorded.

Interventions

Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, do PROCEDURE

Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.

Pre-emptive Local Anesthesia

Pre-emptive Local Anesthesia PROCEDURE

Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.

Pre-emptive Local Anesthesia

Articaine Hydrochloride With Epinephrine DRUG

Articaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group. The total volume, total dose, dose per kilogram, and injection sites will be recorded.

Pre-emptive Local Anesthesia

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7 to 12 years
• ASA physical status I or II
• Scheduled for ambulatory dental treatment under general anesthesia
• Ability to understand and respond to age-appropriate pain and recovery assessment tools
• Written informed consent obtained from a parent or legal guardian
• Child assent obtained when appropriate

You may not qualify if:

• Known allergy or contraindication to local anesthetic agents
• Developmental delay or cognitive impairment preventing assessment
• Autism spectrum disorder or severe behavioral disorder
• Neurological disease affecting behavior or consciousness
• Chronic analgesic or sedative medication use
• Severe hepatic, renal, cardiac, or respiratory disease
• Emergency dental procedure
• Need for postoperative hospital admission
• Inability to complete postoperative assessment tools

Sponsors & Collaborators

• seher orbay yasli: lead

Study Sites (1)

Erciyes University Faculty of Dentistry

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Carticaine; Epinephrine

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Seher Orbay Yaşlı, Assistant Professor of Anesthe

CONTACT

+905052401933; sehersin81@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinician performing the local anesthesia cannot be masked. Post-anesthesia care unit assessments, including emergence behavior, pain, sedation level, and recovery quality, will be performed by an outcomes assessor blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Reanimation

Model Details: Participants will be randomized in a 1:1 ratio to either pre-emptive local anesthesia or no local anesthesia during ambulatory pediatric dental general anesthesia.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

TU (1)