Hôpital Bretonneau
Paris, 75018, France
NCT Number: NCT02084433
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
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Notify Me7 year–15 year
All sexes
Interventional
Not applicable
Paris, 75018, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
"1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "
para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia
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
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)
Time frame: 1 hour
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
Assistance Publique - Hôpitaux de Paris
Other
Acronym: QUICK
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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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