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

ConditionsEmergence DeliriumPediatric Dental General AnesthesiaPostoperative Recovery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
Sponsorseher orbay yasli

About this trial

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 delirium, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal Pediatric Anesthesia Emergence Delirium Scale score during the first 30 minutes in the post-anesthesia care unit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pre-emptive Local Anesthesia

    Procedure/Surgery

    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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Pre-emptive Local AnesthesiaExperimental treatment 2 interventions
Group B: No Local AnesthesiaNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery

Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale. The scale includes five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and consolability. Each item is scored from 0 to 4, with a total score ranging from 0 to 20. Higher scores indicate more severe emergence delirium symptoms. Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1.

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

Secondary outcomes

1

Postoperative Pain Score

Pain will be assessed using the Faces Pain Scale-Revised. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

Time frame
PACU minutes 0, 5, 10, 15, and 30
2

Recovery Quality Before Discharge

Recovery quality will be assessed using the QoR-15 Pictorial form before discharge. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery quality.

Time frame
Before discharge on day of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

seher orbay yasli

Lead sponsor

TC Erciyes University

Sponsor institution

Source ClinicalTrials.gov

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