Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia (PEDLA-QOR)
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
연구 개요
상태
상세 설명
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 behavioral and pain assessment. Emergence behavior will be evaluated using a PAED-derived 3-item emergence behavior assessment 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 early emergence behavior, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Seher Orbay Yaşlı, Assistant Professor of Anesthe
- 전화번호: +905052401933
- 이메일: sehersin81@hotmail.com
연구 장소
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Kayseri
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Kayseri, Kayseri, 터키 (Türkiye), 38039
- Erciyes University Faculty of Dentistry
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연락하다:
- SEHER Orbay Yaşlı
- 전화번호: 05052401933
- 이메일: sehersin81@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Pre-emptive Local Anesthesia
Children randomized to this group will receive pre-emptive local anesthesia administered by the pediatric dentist before the dental procedure under general anesthesia.
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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.
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 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.
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간섭 없음: No Local Anesthesia
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Emergence Behavior Score During the First 30 Minutes in the Post-Anesthesia Care Unit
기간: PACU minutes 0, 5, 10, 15, and 30
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Emergence behavior will be assessed using a PAED-derived 3-item emergence behavior assessment including eye contact, purposeful behavior, and awareness of surroundings.
Each item is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate greater emergence behavior disturbance.
Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1.
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PACU minutes 0, 5, 10, 15, and 30
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Score
기간: PACU minutes 0, 5, 10, 15, and 30
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Pain will be assessed using the Faces Pain Scale-Revised.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
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PACU minutes 0, 5, 10, 15, and 30
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Recovery Quality Before Discharge
기간: Before discharge on day of surgery
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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.
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Before discharge on day of surgery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PEDGA-LA-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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출현 섬망에 대한 임상 시험
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Bozok University모병수술 후 합병증 | 소아 환자 | 수술 전 불안 (Ameliyat Öncesi Anksiyete) | Emergence Delirium (Derlenme Deliryumu)터키 (Türkiye)