Objective: Adequate analgesia during intravenous cannulation.Hypothesis: Xylocaine spray for the placement of an infusion decreases the pain score with two or more points in comparison to placebo spray.Studie questions:Primary: Has xylocaine spray…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijnstillend effect van cutaan aangebrachte xylocaine spray voor plaatsing van een infuus.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: The pain score of the tested subjects during intravenous
cannulation
Secondary outcome
Secundary outcome(s):
- Complications or adverse reactions of xylocaine spray
- Influence of xylocaine spray in successfully placing an IV cannulation
- The degree of difficulty in successfully placing an IV cannulation
Background summary
EMLA plasters or cream (lidocaine and prilocaine) and Rapydan plasters or cream
(lidocaine and tetracaine) are currently being used as a local anesthetic for
the intravenous cannulation in children. The maximum effect of EMLA occurs
after 1-2 hours. Rapydan works faster and has a maximum effect after 30
minutes. However, Rapydan plasters (5.35 euro) and cream (2 grams: 3.67 euros)
are more expensive than EMLA patches (2.79 euro) and cream (2 grams: 1.73
euros). During an acute care for a child in the emergency department, these
means for analgesia for intravenous cannulation is less suitable. Xylocaine
Spray is used in the anesthesia of the mucosa during oral surgery. It has
within 1-3 min a local anesthetic effect. It is relevant to know whether
cutaneous use of xylocaine spray has a faster anesthetic effect than EMLA or
Rapydan (cream or plasters), in order that children, during an acute care in
the emergency department, experience less pain during intravenous cannulation.
Study objective
Objective: Adequate analgesia during intravenous cannulation.
Hypothesis: Xylocaine spray for the placement of an infusion decreases the pain
score with two or more points in comparison to placebo spray.
Studie questions:
Primary: Has xylocaine spray an analgesic effect during the insertion of an
intravenous cannulation?
Secondary: Are there any side effects when using xylocaine spray? Does
xylocaine spray affect the successful placement of an intravenous cannulation?
Study design
The enrolled subjects will get an intravenous cannulation in both elbows. The
influence of the left or right-handedness is reduced by randomizing the arms of
the subjects in the placebo group or xylocaine group. The subject will get
before xylocaine spray is placed, the intervention-arm, one intravenous
cannulation in one of the elbows, the other intravenous cannulation is placed
in de other arm before placebo spray is placed, the control arm. The pain score
during insertion of de cannulation, the incidence of adverse events and the
success rate and degree of difficulty to place an intravenous cannulation. The
subjects and the one who place the cannulations will be blinded to the
treatment.
Intervention
See the note in the study design.
Study burden and risks
The enrolled subjects will get an intravenous cannulation in both elbows. An
infection will be able to occur at the location of the insertion hole after
removal of the intravenous cannulation.
Possible side effects of xylocaine or placebo spray could occur, for example,
local allergic skin reactions.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
Adults (aged 18 or older)
Signing of the informed consent paper
Exclusion criteria
Allergy for xylocaine
Pregnancy or breast-feeding
Peripheral neuropathy
Analgesics in the last 24 hours
Skin conditions (eczema, psoriasis, infection, or abrasions)
Difficulties in verbal communication
No intravenous access in both elbows possible (eg status after axillary dissection)
Design
Recruitment
Medical products/devices used
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 | EUCTR2015-003915-39-NL |
ClinicalTrials.gov | NCT02562144 |
CCMO | NL54811.075.15 |