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

Key facts

Who runs it
seher orbay yasli
Where
Türkiye1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
80 people, planned
Started
Jun 2026
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Pre-emptive Local Anesthesia
  • Articaine Hydrochloride With Epinephrine
Record updated
9 June 2026

Who can take part

Age
7 years to 12 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Chronic analgesic or sedative medication use
  • 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
  • Severe hepatic, renal, cardiac, or respiratory disease
  • Emergency dental procedure
  • Need for postoperative hospital admission
  • Inability to complete postoperative assessment tools

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 7 and 12 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Pre-emptive Local AnesthesiaTreatment being tested

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

    Treatment: Pre-emptive Local Anesthesia and Articaine Hydrochloride With Epinephrine

  • No Local AnesthesiaNo study treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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
Fit questions
Built from NCT07604337, who can take part
Record updated
9 June 2026