Postoperative Complications
Conditions
Brief summary
Use of local anaesthesia during full mouth dental rehabilitation under general anaesthesia is an everyday practice. It enables better control of the post-extraction bleeding and better control of physiological responses. Postoperative numbness and lip and cheek biting can be an undesired side effect. With our research, we aim to compare two different types of local anaesthesia in relation to postoperative side effects. We also aim to assess the oral health-related quality of life after treatment in general anaesthesia to enlighten how full mouth rehabilitation affects a child's life.
Detailed 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, 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.
Interventions
PROCEDUREExtraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia
QuickSleeper 5 with DHT needles or carpule with periapical/nerve block needles will be used to administer local anaesthetic before teeth extraction in general anaesthesia.
Sponsors
University of Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Intervention model description
The double-blinded prospective randomised study
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
\- Paediatric patients intended for dental treatment in general anaesthesia
Exclusion criteria
* Patients who can not express feelings adequately, * patients where there will not be any teeth extracted, * patients whose parents do not want to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores before and over 48 hours after tooth extraction in general anaesthesia in the two study groups using The Children's Hospital of Eastern Ontario Pain over Scale (CHEOPS) | an average 51 hours (monitoring of pain will be performed one hour before the general anesthesia treatment, 2 hours after treatment, 12 hours after treatment, 24 and 48 hours after treatment | Monitoring's the pain with CHEOPS which evaluates crying, face expression, speech, body movement, touching of the painful area and leg movement. Each category has specific points according to the level of behaviour. Points are added and final scores range between 4-13 points. The number of scores at different measuring points before and over 48 hours after treatment will be compared between the two study groups. |
Countries
Slovenia
Outcome results
None listed