A:To get insight whether respiratory support in the neonatal population, as artificially ventilation and Nasal Continously Positive Airway Pressure, will give an increased stress or pain respons which only can be detected by a 24 hours SCA…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency and intensity of pain response en pain sensation by Skin Conductance
measurement.
Correlation between SCA and Comfortneo scale in pain response.
Secondary outcome
Continous measurement of heart rate, bloodpressure, oxygen saturation,
respiration and temperature.
Background summary
In the neonatal intensive care unit (NICU) newborns frequently are submitted
to painful procedures like blood sampling by heellances, endotracheal
suctioning and inserting tubes. It is well known that newborns demonstrate an
increase sensitivity of pain which may affect clinical or neurodevelopment
outcomes. So it is important to detect pain early and start a treatment.
Detection of pain in this patient group is difficult because of the inability
of verbal expression, the weak muscle structure to express in behavioural
response and the vulnerable physiological response. Pain behaviour observation
scales ( as Comfortneo scale, Neonatal Infant Pain Scale, Premature Infant Pain
Profile, Cries) are used to observe distress and pain and start pain management
conform the protocol. Although these are valid behavior observation scales,
there is still a subjective interpretation.
A skin conductant algesi meassure ( SCA) is a valid method to evaluate pain and
distress in newborn on changes in skin conductance caused by nociceptive
incentives induced by emotional palmar and plantar sweating in 1-2 seconds due
to symphatic nerve activity. An increase in the number of fluctuations and an
increase of the baseline on the screen can be interpreted as a pain response.
Roeggen et al ( 2012) established a baseline of SCA activity in hospitalised
infants at rest (1). This can be used as a reference in our study.
L. Pareira da Silva ( 2011) concluded that the SCA is able to differentiate
nociceptive pain response to acute pain of different durations such as a
heellance for bloodgas analysis( longer duration) and heellance for glycaemia
analysis ( short duration time) (2). Although the NIPS score and the SCA peaks
were both increased, significant higher SCA area under low peaks index were
only registered when blood was drawn for blood gas analysis.
Gjerstad et al ( 2008) showed that the number of SCA fluctuations during
endotracheal suctioning in artificially ventilated children between 1 day and
11 years better correlated with the increased Comfort scale than heart rate and
arterial bloodpressure (3).
In the treatment of neonates there is always a discussion whether the pain
behaviour scale is also valid for the most youngest group, the neonates between
22- 27 weeks gestation. These neonates react different on pain response because
of their prematurity. The use of the SCA can help in this interpretation as
Munster et al ( 2012) showed that the SCA is able to differentiate pain and
discomfort in neonates between 22 - 28 weeks gestational age (4). Only
Valkenburg et al ( 2012) showed influence of temperature regulation on the SCA
outcome in a small study with 11 postoperative newborns with a low Comfortneo
scale ( assumed to have no pain) . The SCA was measured for 60 minutes.
All the other studies were based on short painful moments as heellance and
endotracheal suctioning which are assumed to be painful.
In our NICU the Comfortneo scale is used as a standard for 3 times a day, or
more when necessary. Despite these 3 measure moments we don't have exact
information about the painmoments during the day. At this moment pain treatment
depends on the subjective interpretation and the Comfortneo scale outcome.
Although pain is often related on painful treatments, it is not clear how long
a pain sensation will last. A continuously measurement should give important
information about the painful moments but also about the standard care as
example the ventilated newborns or newborns on Nasale Continously Positive
Airway Pressure ( NCPAP). Ventilated newborns never receive pain medication
automatically, as used in adults. Bellu et al ( 2008) described the possible
adverse effects on the neurodevelopment outcome when using standard opioids in
ventilated newborns. He advised to use opioids only when there is a clear pain
response. Also NCPAP can be assumed to be a stressful or painful treatment
because of the tight connection on the head and nose, especially in active
newborns.
Study objective
A:To get insight whether respiratory support in the neonatal population, as
artificially ventilation and Nasal Continously Positive Airway Pressure, will
give an increased stress or pain respons which only can be detected by a 24
hours SCA meassurement, compared to the standard three times a day meassuremnt
of de Comfortneo scale.
B:To compare the painscore measured by the SCA with te pain score measured by
the Comfortneo scale during standard three times measurment.
Study design
In a 2 months pilot observational cohort study, the painrespons in newborns
with respiratory support (artificially ventilation or NCPAP) will be monitored
by the SCA during 24 hours.The SCA pain response will be measured and scored
continuously. The Comfortneo scale will be taken conform protocol: 3 times a
day. The correlation between those 2 instruments will be compared at the
moments of the Comfortneo scale measurement.
Intervention
Fixating the skinelectrode on the palmar and plantarlocation during 24 hours.
Measuring emotional palmar and plantar sweating.
Study burden and risks
We expect that fixation of the skin electrode will not give adverse effects on
parent-child contact in this stage.
The burden is expected to be low. The skin electrode can be removed without
causing any skin lesions.
Geert Grooteplein 10
Nijmegen 6500 HB
NL
Geert Grooteplein 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Gestationale age 26-42 weeks
- Postnatale age between 24-72 hours
- Artificial ventilation or NCPAP from 4 hours post partum en the exptective duration for at least 24 hours.
Exclusion criteria
-Newborns with changes in respiratory support after birth until the end of the observation period.
-Newborns with palmar or plantar skin injuries
-Newborns with recent ( within 5 days) surgery.
-Newborns with congenital anomaly
Design
Recruitment
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 |
---|---|
CCMO | NL40833.091.12 |