Pain Clinical Trial
Official title:
Ultrasound Guided Central Line Insertion in Neonates: Pain Score Results From a Prospective Study
Central venous access is an imperative measure used in neonates whether being a
peri-operative measure for children undergoing cardiac procedures for congenital heart
diseases or as a mean of nutrition in neonatal enteral malnutrition and drug administration
in oncology patients. Central catheters fall into two categories, a peripherally inserted
central catheter (PICC) line or centrally inserted central catheters (CICC). Although these
two modalities practically have the same aim, identifying the more effective technique is
imperative for deciding which procedure should be applied to ameliorate patient outcomes.
Many studies have been previously done that delineate the indications for central venous
access with practically no absolute contraindications. These indications include central
venous pressure (CVP) monitoring, poor venous access, volume resuscitation, and prolonged
venous access in critically ill patients, total parenteral nutrition (TPN), cardio-pulmonary
resuscitation and medication administration. Centrally inserted catheters have evolved from
being blindly inserted catheters using landmarks techniques, is the usual standard of care,
to being placed under direct visualization using ultrasound guidance. Since its first use
back in the 90's, ultrasound guided insertion of central venous catheters has gained
attention and successful attempts have been made to improve this technique. US-guidance
initially used acoustic Doppler techniques but is now largely replaced by two-dimensional
(2D) imaging and internal jugular vein (IJV) being the preferred site of insertion by US over
femoral and subclavian vein. Several studies have compared these two techniques.
Small-caliber vessels remain a great challenge in the pediatric population which backup the
use of imaging modalities for a successful and safer insertion of CVCs.
This study aims to develop a better understanding of pain during central line insertions,
compare pain scores between the two techniques in order to adopt the less painful technique
and ultimately provide insight about the use of analgesics during these procedures for a
better outcome.
A single-center prospective randomized controlled study of neonates (preterm and term babies)
who underwent an elective or emergent central line insertion between November 2016 and May
2017 was conducted at SGHUMC Neonatal Intensive Care Unit. Hospital's Institutional Review
Board approved the study and an informed parental consent was signed for study entry.
Inclusion criteria included neonates requiring TPN, antibiotic therapy for at least 7 days,
and babies with poor or difficult venous access. Exclusion criteria included refusal to sign
consent, patients with previously attempted or placed central lines, and patients who were
converted from one technique to the other. Patients were randomized into the control and
intervention group through a flip of coin each time a patient enrolled in the study The
catheter used for all the patients was an epicutaneo-cava-catheter (ECC), silicone tube
material kit, 24G, VYGON® (Aachen, Germany). All procedures were performed under sterile
precautions such as hand washing, use of sterile gloves and gowns, facemask, hair cover, and
protective eyewear.
The control group consisted of neonates who underwent a PICC line placement. The method of
insertion performed followed the procedure previously described by Pettit. Patients in the
intervention group underwent US-IJV. This procedure was carried out as follows: The patient's
skin was sterilized with chlorhexidine gluconate and the area was infiltrated with local
anesthetic agent (lidocaine). Vascular cannulation was performed using the ECC's winged
needle. The target vessel was located via the US dynamic (real-time) method. At the point of
needle insertion, the ECC was placed through the needle without guide wire placement. Once
the catheter was inserted, a gentle aspiration was performed to show blood flow through the 3
ml syringe that was connected to the ECC. The catheter was then secured and fixed with simple
steri-strips and covered by the transparent dressing. Both techniques were performed by two
institutional neonatologists who according to their expertise, one performed all PICC line
placements while the other performed all US-IJV.
Transducer selection and the axis of visualization are important to consider in the use of US
for ECC, as such a linear 6-13 MHz transducer Sonosite M-turbo was used (manufacturer's
recommendations). The transverse view shows the vessel under the transducer and the adjacent
structures. The tip of the needle is visualized and inserted at a 45° angle. The longitudinal
view helps to track the needle progression toward the IJV. Post procedural chest radiography
was done for both groups to confirm placement and evaluate for complications.
The primary outcome measured was the pain score difference between Ultrasound inserted
central line and peripherally inserted central line. The pain score was measures using the
Neonatal Pain, Agitation and Sedation Scale (N -PASS). The N-PASS is based on several
criteria: crying / irritability, behavior / state, facial expression, extremities / tone and
vital signs. Patient characteristics such as gestational age, age, gender, admission
diagnosis, weight have been taken into account and the scores was recorded by the nurse in
charge of the baby before and during the procedure. Pain score difference was calculated by
subtracting the score during the procedure from the pain score before the procedure.
The secondary outcome measures included the number of first successful attempts, number of
total attempts and procedure duration. Additional patient information collected included
gender, TPN administration, gestational age, birth weight and diagnosis.
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