The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia

Postoperative Complications Clinical Trial

Official title:

The Effect of Two Local Anaesthesia Techniques on the Paediatric Patient's Recovery After Dental Treatment in General Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156334
• Other study ID #: 2019/01
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: September 28, 2022

Study information

• Verified date: November 2022
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 28, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• Extraction 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.

Locations

Country	Name	City	State
Slovenia	University medical centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

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):744-7 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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