Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-emptive Local Anesthesia, Articaine Hydrochloride With Epinephrine.
- Who it may be relevant to
- Registry conditions: Emergence Delirium, Pediatric Dental General Anesthesia, Postoperative Recovery. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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.
Interventions
- Procedure Pre-emptive Local Anesthesia
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. - Drug Articaine Hydrochloride With Epinephrine
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 outcome measures
- Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery [Time frame: PACU minutes 0, 5, 10, 15, and 30]
Secondary outcome measures (2)
- Postoperative Pain Score [Time frame: PACU minutes 0, 5, 10, 15, and 30]
- Recovery Quality Before Discharge [Time frame: Before discharge on day of surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Erciyes University Faculty of Dentistry — Kayseri
Identifiers
NCT: NCT07604337 · PEDGA-LA-2026