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Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia (PEDLA-QOR)

20. maj 2026 opdateret af: seher orbay yasli

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

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 behavior, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal emergence behavior score during the first 30 minutes in the post-anesthesia care unit.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Seher Orbay Yaşlı, Assistant Professor of Anesthe
  • Telefonnummer: +905052401933
  • E-mail: sehersin81@hotmail.com

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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, do
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.
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.
Medicin: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Emergence Behavior Score During the First 30 Minutes in the Post-Anesthesia Care Unit
Tidsramme: PACU minutes 0, 5, 10, 15, and 30
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.
PACU minutes 0, 5, 10, 15, and 30

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain Score
Tidsramme: 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.
PACU minutes 0, 5, 10, 15, and 30
Recovery Quality Before Discharge
Tidsramme: 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.
Before discharge on day of surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

seher orbay yasli

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PEDGA-LA-2026

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