Condition category
Surgery
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Judith Versloot

ORCID ID

Contact details

Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Louwesweg 1
Amsterdam
1066 EA
Netherlands
+31 (0)20 5188243
j.versloot@acta.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR475

Study information

Scientific title

Computerized anaesthesia delivery system (Wand) versus traditional syringe: comparing pain and pain-related behaviour in children

Acronym

WAND

Study hypothesis

Does the use of the Wand system reduce pain related behavior during the local anaesthesia injection in children?

Ethics approval

Not provided at time of registration

Study design

Randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Anesthesia injection, local

Intervention

Local anesthesia injection with a computerised anaesthesia delivery system (Wand) or the traditional syringe.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/10/2005

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 4-11 years
2. Needing two treatment sessions
3. Dutch speaking

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

Special education

Recruitment start date

01/10/2005

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academisch Centrum Tandheelkunde Amsterdam (ACTA)
Amsterdam
1066 EA
Netherlands

Sponsor information

Organisation

Academic Centre Dentistry Amsterdam (ACTA) (Netherlands)

Sponsor details

Louwesweg 1
Amsterdam
1066 EA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Interuniversity Dentistry Research School (IOT) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academic Centre Dentistry Amsterdam (ACTA) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18493254

Publication citations

  1. Results

    Versloot J, Veerkamp JS, Hoogstraten J, Pain behaviour and distress in children during two sequential dental visits: comparing a computerised anaesthesia delivery system and a traditional syringe., Br Dent J, 2008, 205, 1, E2; discussion 30-1, doi: 10.1038/sj.bdj.2008.414.

Additional files

Editorial Notes