Intra‑osseous anesthesia for removing a permanent molar in children under general anesthesia
The Effectiveness of Intra-osseous Anaesthesia in Reducing Immediate and Delayed Post-operative Complications Associated With the Extraction of First Permanent Molars Under General Anaesthesia: A Randomised Controlled Trial
NA · University Hospital, Ghent · NCT07108439
We'll test whether intra‑osseous (tooth‑only) anesthesia given to children aged 6–12 having a permanent molar removed under general anesthesia reduces postoperative pain, numbness, and accidental lip or cheek biting.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07108439 on ClinicalTrials.gov |
What this trial studies
This is a randomized interventional study at Ghent University Hospital comparing intra‑osseous local anesthesia (Quicksleeper 5) given just before extraction with no intra‑osseous anesthesia in children undergoing removal of a first permanent molar under general anesthesia. The operator performs limited mucosal anaesthesia, bone perforation, and injection into the bone so the tooth — not surrounding soft tissues — is numbed. Children are randomly assigned to one of the two groups and assessed with short questions and observations before and after the procedure for pain, anxiety, and immediate and delayed postoperative delirium. Extractions are performed at the end of the dental treatment under nasal intubation and patients are followed for early postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 6–12 with ASA I–II who need extraction of at least one first permanent molar under general anesthesia, are cooperative for pre‑ and post‑operative measurements, have no allergy to local anesthetics or hematologic disorders, and whose parent/guardian can provide written informed consent.
Not a fit: Children who require a traumatic extraction, use a laryngeal mask instead of nasal intubation, have allergies to local anesthetics, hematologic conditions, or whose family does not speak Dutch are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the technique could reduce postoperative pain and soft‑tissue numbness, lower the risk of accidental lip or cheek biting, and decrease the need for painkillers in children.
How similar studies have performed: Intra‑osseous anesthesia has been used in dentistry and can provide tooth‑focused numbness with less soft‑tissue anesthesia, but randomized pediatric data specifically for extractions under general anesthesia are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \- 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 Exclusion Criteria: * \- Treatment with a laryngeal mask * If a traumatic extraction is needed, this patient is excluded from the study * Children who do not meet the inclusion criteria * Deviation in the pain relief protocol * Parents/child don't speak Dutch * Patients with missing data during the procedure/follow-up
Where this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (RECRUITING)
Study contacts
- Principal investigator: Chloë Sterkens — Equal Lifelong Oral Health for All Research Group, Paediatric Dentistry
- Study coordinator: Sivaprakash Rajasekharan, BDS,MSc,PhD
- Email: siva.rajasekharan@uzgent.be
- Phone: +3293324008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: No Condition, Assessment of Healthy Volunteers, Intra-osseous anesthesia, pain management