Research with human participants

Overview of medical research in the Netherlands

A randomised clinical trial on the effectiveness of Emla and Rapydan for prevention of vena punction-induced pain in children.

Published:
Last updated:

To study whether a novel plaster (Rapydan) is more successfull in diminishing pain/ discomfort than the usual plaster (EMLA).

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Observational non invasive

ID

NL-OMON35993

Source

ToetsingOnline

Brief title

Pain perception after vena punction.

Condition

  • Other condition

Synonym

Pain perception/ discomfort

Health condition

Pijnbeleving

Research involving

Human

Sponsors and support

Primary sponsor :
Isala Klinieken
Source(s) of monetary or material Support :
Isala Klinieken en producent Ripidan pleister

Intervention

Keyword :
Children, Discomfort, Pain perception, Vena punction

Outcome measures

Primary outcome

Pain score on "pain face-scale".

Secondary outcome

Redness, Swelling, Access to the vein.

Background summary

Sedative plasters are usually admitted, prior to vena punction (blood sampling)
in young children. The purpose of sedative plasters is to prevent (severe)
pain/ discomfort.

Study objective

To study whether a novel plaster (Rapydan) is more successfull in diminishing
pain/ discomfort than the usual plaster (EMLA).

Study design

Randomised Clinical Trial

Study burden and risks

Potential allergic reaction.

Public
Isala Klinieken

Dokter van Heesweg 2
8000 GK Zwolle
NL
Scientific
Isala Klinieken

Dokter van Heesweg 2
8000 GK Zwolle
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Children (2-11 years)

Inclusion criteria

Age 3 - 18

Exclusion criteria

Allergy for the contents of the plaster

Design

Study phase :
4
Study type :
Observational non invasive
Masking :
Double blinded (masking used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
200
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
EMLA
Generic name :
LIDOCAINE/PRILOCAINE
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
RAPIDAN
Generic name :
LIDOCAINE/TETRACAINE
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Isala Klinieken (Zwolle)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC Isala Klinieken (Zwolle)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2011-000750-37-NL
CCMO NL35711.075.11