Effectiveness of dental local analgesia among children for dental extractions

Phase 4

Withdrawn

Conditions: dental local analgesia
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology - Anaesthetics

Registration Number: ACTRN12610000889055

Lead Sponsor: Dental Health Services Western Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: All

Target Recruitment: 50

Inclusion Criteria

Child registered with Dental Health Services WA. Child requires bilateral maxillary permanent teeth requiring extractions as part of orthodontic treatment as requested by specialist orthodontist

Exclusion Criteria

There must be no:
a. History of allergy to local anaesthetic or any of its constituents.
b. Medical conditions contraindicating the use of local analgesia or to undergo dental treatment under local analgesia.
c. medications being taken likely to interfere with reporting of pain (analgesics).
d. Neurological disorders with sensory disturbances or communication difficulties.
e. Non-cooperative behaviour for dental treatment under local analgesia.
f. Difficulty with communicating effectively in the English language.
g. Possibility of pregnancy.
h. Evidence of soft tissue infection/inflammation near site of injection.
i. body weight below 30 kg.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children with achievement of local analgesia through buccal infiltration alone to allow extraction of upper teeth among study participants. Achievement of analgesia initially tested through tactile probing after maximum of ten minutes wait after analgesia administration. If analgesia is deemed adequate extraction is performed.[ Analgesia tested after 10 minutes from administration of local analgesia.]

Secondary Outcome Measures

Name	Time	Method
Child's report of pain as reported through the faces pain scale[ After completion of local analgesia administration and after extraction. If both teeth are extracted at the same visit the recorder ensures that child's response is for the indicated tooth.];Assistant observation of child's reaction to administration of local analgesia and during extraction using the CHEOPS scale[ Assistant record the observations during local anaesthetic administration and during extraction];Parental report of postoperative pain through completion of parent questionnaire[ Questionnaire completed 24 hours after completion of the procedure.];Reports of adverse events pain at injection site, excessive and or prolonged post operative bleeding and soft tissue injuries.[ Verbal reports obtained through phone contact or text messaging 24 hours after completion of extraction.]