Usefulness of Intraosseous Anesthesia for Permanent Tooth Extraction Under GA in Pediatric Dental Treatment

NCT07108439 | Recruiting

• 1 other identifier: ONZ-2025-0166
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing a study to see if a new way of giving local anesthesia during dental surgery can help children feel better after having a tooth removed under general anesthesia (when they are fully asleep). Normally, dentists give numbing medicine that can leave the lips or cheeks numb. This sometimes causes children to bite themselves without realizing it, which can make them upset when they wake up. In this study, the investigators are testing a special technique called intra-osseous anesthesia, which numbs only the tooth and not the surrounding soft tissues. The investigators hope this will reduce pain after surgery without causing numbness or accidental biting. Children in the study will be randomly placed into one of two groups: one group will receive this special anesthesia before the tooth is removed, and the other group will not. Before and after the procedure, the investigators will ask some short questions and observe the participants to check for pain, anxiety, or confusion. The parents of the participants will also receive a short online questionnaire to fill out the day after the procedure. The goal is to find out if this method helps children wake up more comfortably, feel less pain, and avoid side effects. This could improve how dentists care for children during dental treatments in the future.

Conditions

No Condition, Assessment of Healthy Volunteers

Keywords

Intra-osseous anesthesia; pain management

Outcome Measures

Primary Outcomes (4)

• postoperative delirium in the child (flowchart)

  to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative delirium in the child. Postoperative delirium will be assessed 5 min after spontaneous eye opening using a validated flowchart

  5 minutes after spontaneous eye opening

• Pre- and postoperative pain in the child (Visual Analogue Scale - VAS)

  to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at a fixed time after the procedure (after 120 minutes) using the validated VAS (Visual Analogue Scale) scale. Upon arrival at the hospital, the preoperative VAS will be taken. The scale consists of a line of numbers from 0 (left side of the line) to 10 (right side of the line). The higher the number, the more pain, so a worse outcome.

  Preoperative: upon arrival at the hospital Postoperative: after 120 minutes

• Pre- and postoperative pain in the child (Face-Legs-Activity-Cry-Consolability Scale)

  to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at fixed times after the procedure (after 10/30/60/120 minutes) using the validated FLACC (Face-Legs-Activity-Cry-Consolability Scale) scales. Upon arrival at the hospital, the preoperative FLACC will be taken. The scale consists of 5 scores assigned by an observer based on child's behavior/attitude. The sum of these determines the pain. 0 is no pain, 10 is intense pain. The higher the score, the outcome is worse.

  Preoperative: arrival at the hospital, postoperative: after 10,30,60,120 minutes

• Pre- and postoperative anxiety in the child (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale)

  to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative anxiety in the child. Postoperative anxiety will be assessed at a fixed time after the procedure (after 120 minutes) using a validated scale (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale). The scale consists of 15 questions with a score from 1 till 5. A score of 15 in total means no anxiety, a higher score means more dental anxiety/fear, so a worse outcome.

  Preoperative: upon arrival at the hospital Postoperative: after 120 minutes

Secondary Outcomes (1)

• presence of postoperative side effects related to local anesthesia

  10 minutes up to 24 hours 10, 30, 60, 120 minutes after waking up (VAS - Visual Analogue Scale, FLACC - Face, Legs, Activity, Cry and Consolability, CFSS-DS- Children's Fear Survey Schedule - Dental Subscale questionnaire). After 24 hours: QoR-15

Other Outcomes (1)

• Possible influence of the child's gender, site of extraction (maxilla or mandible/left or right)

  up to 24 hours

Study Arms (2)

intra osseous administration of local anesthesia during general anesthesia

EXPERIMENTAL

Intra osseous administration of articain 4% 1/100 000 during general anesthesia for the extraction of a first permanent molar. The administration will be done with Quicksleeper 5.

Other: Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia

Control group

NO INTERVENTION

Normal procedure: no local anesthesia for the extraction of a first permanent molar during general anesthesia

Interventions

Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia OTHER

Intra osseous administration of articain 4% 1/100 000 during general anesthesia for the extraction of a first permanent molar. The administration will be done with Quicksleeper 5.

intra osseous administration of local anesthesia during general anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Children between 6 and 12 years old, belonging to the category of ASA I or II according to the 'American Society of Anaesthesiologists'
• Children who are cooperative enough for pre- and post-operative measurements
• Children who are not allergic to components of local anaesthesia
• Children who need at least one extraction of a FPM
• Children without a hematological condition
• Children who haven't taken painkillers 48 hours before the procedure
• Patients who need a treatment under general anaesthesia (nasal intubation) due to polycaries/fear/anxiety.
• Able to obtain a written consent from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes

You may not qualify if:

• \- Treatment with a laryngeal mask
• If a traumatic extraction is needed, this patient is excluded from the study
• Deviation in the pain relief protocol
• Parents/child don't speak Dutch
• Patients with missing data during the procedure/follow-up

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chloë Sterkens

  Equal Lifelong Oral Health for All Research Group, Paediatric Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sivaprakash Rajasekharan, BDS,MSc,PhD

CONTACT

+3293324008; siva.rajasekharan@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding is performed using a 6 digit code generated randomly using www.random.org. This code shall be used in all the patients files and shall only be known to the trial administrator. It is a double blind study in which the operator knows whether she is giving intra-osseus anesthesia (articaine) or not, but the patient and the evaluator of the pre- and post- operative scales will not know if the patient got local anaesthesia or not. SR has the excel file with the results of the block randomisation and key for blinding (pseudonymization). Allocation concealment will be performed by with the sealed envelope technique.SR is independent of the study results. He has no access to the results of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 7, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 6, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)