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NCT Number: NCT07604337

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

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry

Kayseri, 38039, Turkey (Türkiye)

Location contact

SEHER Orbay Yaşlı

CONTACT

[email protected]

05052401933

About this study

This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial in children aged 7-12 years undergoing ambulatory dental treatment under general anesthesia.

Participants will be randomized in a 1:1 ratio to one of two groups: pre-emptive local anesthesia or no local anesthesia. In the pre-emptive local anesthesia group, local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. In the no local anesthesia group, local anesthesia will not be routinely administered. If clinically required, rescue analgesia or additional local anesthesia may be administered at the discretion of the responsible clinician and will be recorded.

Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale. In the post-anesthesia care unit, sedation and arousal will be assessed using the Richmond Agitation-Sedation Scale before each emergence delirium and pain assessment. Emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale at 0, 5, 10, 15, and 30 minutes after arrival in the post-anesthesia care unit, only when the child meets predefined arousal criteria. Pain will be assessed using the Faces Pain Scale-Revised at the same time points. Recovery quality before discharge will be assessed using the QoR-15 Pictorial form.

The study aims to determine whether reducing peri-emergence nociceptive input with pre-emptive local anesthesia improves emergence delirium severity, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery

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

    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.

Secondary outcomes

  1. Postoperative Pain Score

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

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

  2. Recovery Quality Before Discharge

    Time frame: Before discharge on day of surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seher Orbay Yaşlı, Assistant Professor of Anesthe

CONTACT

[email protected]

+905052401933

Sponsors and collaborators

Lead sponsor

seher orbay yasli

Other

Registry information

Official study title

Effects of Pre-emptive Local Anesthesia on Emergence Behavior and Early Recovery Quality After Ambulatory Pediatric Dental General Anesthesia: A Parallel-Group Randomized Controlled Trial

Acronym: PEDLA-QOR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
Jun 9, 2026

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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