Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia (NCT07604337) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia
Turkey (Türkiye)80 participantsStarted 2026-06
Plain-language 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 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.
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery