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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | intraosseous anaesthesia using a computerized system | "1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection " |
| PROCEDURE | conventional anasthesia | para-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.