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

NCT04156334 | Completed

• 1 other identifier: 2019/01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

computer-controlled intraosseous anaesthesia

EXPERIMENTAL

Patients will receive the local anaesthetic using computer-controlled intraosseous anaesthesia (Quicksleeper 5) before the tooth extraction in general anaesthesia.

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

infiltrative or conductive local anaesthesia

EXPERIMENTAL

Patients will receive a local anaesthetic using carpule before the tooth extraction in general anaesthesia.

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

Interventions

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.

computer-controlled intraosseous anaesthesia; infiltrative or conductive local anaesthesia

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Paediatric patients intended for dental treatment in general anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University medical centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related 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):744-749. doi: 10.1016/j.bjoms.2018.08.006. Epub 2018 Aug 22.

  PMID: 30143396 RESULT

• 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.

  PMID: 20020791 RESULT

MeSH Terms

Conditions

Postoperative Complications

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Rok Gašperšič, Phd

  University of Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The double-blinded prospective randomised study

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: November 7, 2019
• Study Start: February 25, 2020
• Primary Completion: June 30, 2022
• Study Completion: September 28, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)