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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Pain reported by the patient according to the visual analogue scale (VAS) [ Time Frame: up to 10 minutes ]

Pain reported by the patient according to the visual analogue scale (VAS) will be evaluated at the end of the injection / infiltration. The assessment will concern the insertion of the needle and the injection / infiltration


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • latency [ Time Frame: up to 15 minutes ]
    latency (in minutes) evaluated by examining the sensitivity of the sulcus using a probe (an exam will be conducted every minute until the sulcus is insensitive to the probe)
  • need for additional anesthesia during the treatment [ Time Frame: 1 hour ]
  • pain felt during the treatment [ Time Frame: 1 hour ]
    need for additional anesthesia during the treatment; pain felt during the treatment evaluated at the end of treatment according to the VAS


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 6, 2014
Date Started: January 2015
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017