Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Postoperative Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The double-blinded prospective randomised studyMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Concealed randomisation table where patients will be consecutively assigned. Every patient will be given a number according to the randomisation table and the study group inclusion will not be revealed to the investigator or patients until the end of the study.Primary Purpose: Treatment

Participation Requirements

Age
Between 3 years and 18 years
Gender
Both males and females

Description

Dental treatment of children under general anaesthesia (GA) is intended for children who, for one reason or another, are unable to participate in the outpatient clinic. When extracting teeth in GA, local anaesthetics (LA) are regularly applied to control bleeding, reduce postoperative sensitivity, a...

Dental treatment of children under general anaesthesia (GA) is intended for children who, for one reason or another, are unable to participate in the outpatient clinic. When extracting teeth in GA, local anaesthetics (LA) are regularly applied to control bleeding, reduce postoperative sensitivity, and to better control vital functions. The side effects of LA can be the patient's irritation due to not understanding the postoperative numbness and lip and cheek biting. The aim of our study is to determine if there is a difference between the two types of local anaesthesia (computer-controlled intraosseous anaesthesia and classical local/conductive anaesthesia) in the frequency and extent of the occurrence of side effects postoperatively. The research data would help establish a better dental extraction protocol for children under GA, which would allow for less postoperative complications.

Tracking Information

NCT #
NCT04156334
Collaborators
Not Provided
Investigators
Study Chair: Rok Kosem, Phd University Medical Centre Ljubljana