effectiveness of local dental anaesthetic in childre

Phase 4

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

Registration Number: ACTRN12610000873022

Lead Sponsor: Dental Health Services, Western Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Stopped early

Sex: All

Target Recruitment: 150

Inclusion Criteria

Child registered with the School Dental Service in Western Australia. Minimum body weight 20 kg.
Require carious bilateral mandibular posterior teeth restored.

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. Signs of irreversible pulpal involvement of the study teeth.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children with successful local analgesia to complete restorations in mandibular posterior teeth. Child's response and report of no sensation of pain on undertaking restorative procedures using conventional air-turbine and engine driven rotary cutting hand-pieces was used as indicator of adequacy and success of local analgesia.[ The restorative procedures commenced 5 minutes after completion of local anaesthetc administration with a further wait of another 5 minutes if discomfort was reported.]

Secondary Outcome Measures

Name	Time	Method
Child's report of pain[ Observations taken by assistant using the faces pain scale after completion of local anaesthetic administration and restorative treatment.];parental report of parent/carer on pain by completing a parent report of pain questionnaire.[ 24 hours after procedure];observation of child's reactions[ during administration of local anaesthetic and during restorative procedures, observations taken by dental assistant using the CHEOPS pain scale.];verbal reports of any adverse events; pain at injection site, pain elsewhere, soft tissue injury (lip biting).[ Contact with child/parent at 2 hours, 4 hours, 24 hours and 7 days after completion of local anaesthetic administration by phone, text messaging.]