Pre-emptive Local Anesthesia and Sevoflurane Consumption in Pediatric Dental Anesthesia

NCT07608900 | Not Yet Recruiting

• 1 other identifier: PED-DENT-SEVO-LA-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate whether pre-emptive local anesthesia reduces sevoflurane consumption during pediatric day-case dental treatment performed under general anesthesia. Children aged 4 to 12 years scheduled for elective dental treatment under general anesthesia will be included. Participants will be assigned to either receive pre-emptive local anesthesia before the dental procedure or receive no pre-emptive local anesthesia. General anesthesia will be standardized using sevoflurane, low fresh gas flow, endotracheal intubation, and bispectral index monitoring. The main outcome will be sevoflurane consumption expressed as mL/kg/hour. Secondary outcomes will include anesthetic agent uptake, time from sevoflurane discontinuation to extubation, and estimated carbon dioxide-equivalent emissions. The aim is to determine whether pre-emptive local anesthesia can reduce volatile anesthetic requirement and improve early recovery while maintaining adequate anesthetic depth in children undergoing dental general anesthesia.

Conditions

Sevoflurane Consumption

Keywords

Pediatric dental anesthesia; Sevoflurane; Sevoflurane consumption; Pre-emptive local anesthesia; Agent uptake; Carbon footprint

Outcome Measures

Primary Outcomes (1)

• Sevoflurane Consumption in mL/kg/hour

  Sevoflurane consumption will be obtained from the Dräger Primus logbook at the end of anesthesia. Sevoflurane will be titrated to maintain bispectral index values within the target range of 40 to 60 in both groups. Consumption will be normalized to body weight and sevoflurane administration duration and expressed as mL/kg/hour.

  Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure

Secondary Outcomes (3)

• Sevoflurane Agent Uptake

  Intraoperative period, from initiation of sevoflurane administration to sevoflurane discontinuation; assessed at the end of each procedure

• Carbon Dioxide-Equivalent Emissions From Sevoflurane Consumption

  Calculated at the end of each procedure using intraoperative sevoflurane consumption

• Time From Sevoflurane Discontinuation to Extubation

  Emergence period, from sevoflurane discontinuation to extubation during each procedure

Study Arms (2)

Pre-emptive Local Anesthesia Group

EXPERIMENTAL

Children randomized to this group will receive pre-emptive local anesthesia before the dental procedure under standardized low-flow sevoflurane-based general anesthesia.

Procedure: Pre-emptive Local Anesthesia; Drug: Articaine With Epinephrine; Drug: Sevoflurane

No Pre-emptive Local Anesthesia Group

ACTIVE COMPARATOR

Children randomized to this group will not receive routine pre-emptive local anesthesia before the dental procedure. Rescue local anesthesia, if clinically required, will be recorded separately.

Drug: Sevoflurane

Interventions

Pre-emptive Local Anesthesia PROCEDURE

Pre-emptive local anesthesia will be administered before the dental procedure according to the planned dental treatment. The application sites, total volume, total dose, and dose per kilogram will be recorded.

Pre-emptive Local Anesthesia Group

Articaine With Epinephrine DRUG

Articaine with epinephrine will be used for local anesthesia before the dental procedure in the pre-emptive local anesthesia group. The total administered volume, total dose, dose per kilogram, and injection sites will be recorded.

Pre-emptive Local Anesthesia Group

Sevoflurane DRUG

Sevoflurane will be used for maintenance of general anesthesia in both study groups. Sevoflurane administration will be titrated to maintain bispectral index values within the target range of 40 to 60 under standardized low-flow anesthesia.

No Pre-emptive Local Anesthesia Group; Pre-emptive Local Anesthesia Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 12 years
• Scheduled for elective day-case dental treatment under general anesthesia
• ASA physical status I or II
• Planned sevoflurane-based general anesthesia
• Planned oral endotracheal intubation
• Eligibility for standardized low-flow anesthesia with fresh gas flow of 1 L/min
• Eligibility for BIS-guided sevoflurane titration
• Written informed consent obtained from a parent or legal guardian

You may not qualify if:

• Age younger than 4 years or older than 12 years
• ASA physical status III or higher
• Emergency dental procedures
• Known allergy or contraindication to sevoflurane
• Known allergy or contraindication to amide local anesthetics, articaine, or epinephrine
• Known or suspected malignant hyperthermia susceptibility
• Significant cardiovascular, respiratory, hepatic, renal, or neurological disease requiring non-standard anesthetic management
• Chronic opioid or sedative use
• Planned airway management other than oral endotracheal intubation
• Dental procedures in which withholding pre-emptive local anesthesia is considered clinically inappropriate for safety or hemostasis
• Refusal of participation by parent or legal guardian

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Interventions

Carticaine; Epinephrine; Sevoflurane

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The anesthesia provider responsible for BIS-guided sevoflurane titration and intraoperative anesthetic management will be blinded to group allocation. The postoperative recovery assessor evaluating PACU stay and Aldrete score will also be blinded to group allocation when feasible. The dental operator administering or not administering local anesthesia cannot be blinded because of the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized into two parallel groups. Children in the pre-emptive local anesthesia group will receive local anesthesia before the dental procedure under general anesthesia. Children in the control group will not receive routine pre-emptive local anesthesia. General anesthesia management, airway management, fresh gas flow, and BIS-guided sevoflurane titration will be standardized in both groups.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05