ISRCTN ISRCTN43755461
DOI https://doi.org/10.1186/ISRCTN43755461
Protocol serial number NTR475
Sponsor Academic Centre Dentistry Amsterdam (ACTA) (Netherlands)
Funders Interuniversity Dentistry Research School (IOT) (Netherlands), Academic Centre Dentistry Amsterdam (ACTA) (Netherlands)
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
26/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Judith Versloot
Scientific

Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Louwesweg 1
Amsterdam
1066 EA
Netherlands

Phone +31 (0)20 5188243
Email j.versloot@acta.nl

Study information

Primary study designInterventional
Study designRandomised open label active controlled parallel group trial
Secondary study designRandomised controlled trial
Scientific titleComputerized anaesthesia delivery system (Wand) versus traditional syringe: comparing pain and pain-related behaviour in children
Study acronymWAND
Study objectivesDoes the use of the Wand system reduce pain related behavior during the local anaesthesia injection in children?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAnesthesia injection, local
InterventionLocal anesthesia injection with a computerised anaesthesia delivery system (Wand) or the traditional syringe.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Occurrence of 5 pain related behaviors observed in 15 s intervals of the injection time.

Key secondary outcome measure(s)

Venham's Distress score (0-5) in 15 s intervals of the injection time and self-reported pain (0-10)

Completion date01/06/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit11 Years
SexAll
Target sample size at registration100
Key inclusion criteria1. Age 4-11 years
2. Needing two treatment sessions
3. Dutch speaking
Key exclusion criteriaSpecial education
Date of first enrolment01/10/2005
Date of final enrolment01/06/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Amsterdam
1066 EA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 12/07/2008 Yes No