The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications
Eligibility Criteria
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
Sites / Locations
- University medical centre Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
computer-controlled intraosseous anaesthesia
infiltrative or conductive local anaesthesia
Arm Description
Patients will receive the local anaesthetic using computer-controlled intraosseous anaesthesia (Quicksleeper 5) before the tooth extraction in general anaesthesia.
Patients will receive a local anaesthetic using carpule before the tooth extraction in general anaesthesia.
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04156334
First Posted
September 12, 2019
Last Updated
November 4, 2022
Sponsor
University of Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT04156334
Brief Title
The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia
Official Title
The Effect of Two Local Anaesthesia Techniques on the Paediatric Patient's Recovery After Dental Treatment in General Anaesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The double-blinded prospective randomised study
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
computer-controlled intraosseous anaesthesia
Arm Type
Experimental
Arm Description
Patients will receive the local anaesthetic using computer-controlled intraosseous anaesthesia (Quicksleeper 5) before the tooth extraction in general anaesthesia.
Arm Title
infiltrative or conductive local anaesthesia
Arm Type
Experimental
Arm Description
Patients will receive a local anaesthetic using carpule before the tooth extraction in general anaesthesia.
Intervention Type
Procedure
Intervention Name(s)
Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rok Gašperšič, Phd
Organizational Affiliation
University of Ljubljana
Official's Role
Study Chair
Facility Information:
Facility Name
University medical centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
non
Citations:
PubMed Identifier
30143396
Citation
Patini R, Staderini E, Cantiani M, Camodeca A, Guglielmi F, Gallenzi P. Dental anaesthesia for children - effects of a computer-controlled delivery system on pain and heart rate: a randomised clinical trial. Br J Oral Maxillofac Surg. 2018 Oct;56(8):744-749. doi: 10.1016/j.bjoms.2018.08.006. Epub 2018 Aug 22.
Results Reference
result
PubMed Identifier
20020791
Citation
Townsend JA, Ganzberg S, Thikkurissy S. The effect of local anesthetic on quality of recovery characteristics following dental rehabilitation under general anesthesia in children. Anesth Prog. 2009 Winter;56(4):115-22. doi: 10.2344/0003-3006-56.4.115.
Results Reference
result
Learn more about this trial
The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia
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