NCT02084433|Completed
Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
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Sponsor study identifier
interventional
158
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2014
Actual (reported)March 12, 2014
Actual (reported)January 2015
Date type not reportedThis date has not been verified as actual or estimated.
February 2017
Actual (reported)February 2017
Actual (reported)Pain reported by the patient according to the visual analogue scale (VAS)
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
up to 10 minutes
latency
up to 15 minutes
need for additional anesthesia during the treatment
1 hour
pain felt during the treatment
1 hour
para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia
intraosseous anaesthesia using a computerized system (Quicksleeper) "1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "
"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
Hôpital Bretonneau
Paris, 75018, France
Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.
Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial. BMJ Open. 2015 Jul 10;5(7):e007724. doi: 10.1136/bmjopen-2015-007724.
Frédéric Courson, PhD
Assistance Publique - Hôpitaux de Paris
158 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2014
First Posted
March 12, 2014
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
February 23, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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