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

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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University medical centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia

Procedure

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 outcomes

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)

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

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.

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Nov 7, 2019
Registry last updated: Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed