Clinical Trials Directory

Trials / Completed

CompletedNCT02084433

Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
158 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
7 Years – 15 Years
Healthy volunteers
Accepted

Summary

The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration. Design: split-mouth design AND parallel-arm design

Detailed description

Local anesthesia is commonly used in oral health care and intra-mucosal infiltration anesthesia is most commonly used by practitioners. Anesthesia may cause children a great deal of anxiety because of the fear of the injection. The latter can be painful if the product is delivered too quickly in the mucosa. Recent developments in the techniques and anesthesia systems allow reducing pain during the injection. In particular, computerized systems (electronically assisted local anesthesia) allow a slow injection limiting pressure. Moreover, these systems look like a pen which prevents the negative impression of the image related to the syringe metal. The intraosseous electronically-assisted anesthesia could be an interesting alternative to conventional infiltration anesthesia by making the act less stressful but also less painful for the child.

Conditions

Interventions

TypeNameDescription
PROCEDUREintraosseous anaesthesia using a computerized system"1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "
PROCEDUREconventional anasthesiapara-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia

Timeline

Start date
2015-01-01
Primary completion
2017-02-01
Completion
2017-02-01
First posted
2014-03-12
Last updated
2017-02-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02084433. Inclusion in this directory is not an endorsement.