Less Pain in Neonates During Central Lines Insertion

Pain Clinical Trial

Official title:

Ultrasound Guided Central Line Insertion in Neonates: Pain Score Results From a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647293
• Other study ID #: IRB/O/036-16/1916
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: August 2018
• Source: Saint George Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• neonates requiring TPN

• antibiotic therapy for at least 7 days

• babies with poor or difficult venous access

Exclusion Criteria:

• refusal to sign consent

• patients with previously attempted or placed central lines

• patients who were converted from one technique to the other

Related Conditions & MeSH terms

• Central Venous Catheter
• Neonates
• Pain

Intervention

Procedure:
• Ultrasound Guided Central Catheter Insertion

• Peripherally Inserted Central Catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saint George Hospital

References & Publications (15)

Al Hamod DA, Zeidan S, Al Bizri A, Baaklini G, Nassif Y. Ultrasound-guided Central Line Insertion and Standard Peripherally Inserted Catheter Placement in Preterm Infants: Comparing Results from Prospective Study in a Single-center. N Am J Med Sci. 2016 May;8(5):205-9. doi: 10.4103/1947-2714.183011. — View Citation

American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee, Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. Erratum in: Pediatrics. 2007 Feb;119(2):425. — View Citation

Bhatt et al. Indications and complications of central venous catheterization in critically ill children in intensive care unit. National Journal of Medical Research 2012;2:1.85-88.

Cheung E, Baerlocher MO, Asch M, Myers A. Venous access: a practical review for 2009. Can Fam Physician. 2009 May;55(5):494-6. Review. — View Citation

Costa P, Camargo P, Bueno M, Kimura A. Measuring pain in neonates during placement of central line catheter via peripheral insertion. Acta Paul Enferm 2010;23(1):35-40.

Davidson A, Flick RP. Neurodevelopmental implications of the use of sedation and analgesia in neonates. Clin Perinatol. 2013 Sep;40(3):559-73. doi: 10.1016/j.clp.2013.05.009. Epub 2013 Jul 12. Review. — View Citation

Goldstein SD, Pryor H, Salazar JH, Dalesio N, Stewart FD, Abdullah F, Colombani P, Lukish JR. Ultrasound-Guided Percutaneous Central Venous Access in Low Birth Weight Infants: Feasibility in the Smallest of Patients. J Laparoendosc Adv Surg Tech A. 2015 Sep;25(9):767-9. doi: 10.1089/lap.2014.0308. Epub 2015 Jul 13. — View Citation

Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. Review. — View Citation

Kumar A, Chuan A. Ultrasound guided vascular access: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):299-311. Review. — View Citation

Pettit J. Technological advances for PICC placement and management. Adv Neonatal Care. 2007 Jun;7(3):122-31. Review. — View Citation

Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. — View Citation

Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. Review. — View Citation

Trieschmann U, Cate UT, Sreeram N. Central venous catheters in children and neonates - what is important? Images Paediatr Cardiol. 2007 Oct;9(4):1-8. — View Citation

Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Ultrasound-guided internal jugular venous cannulation in infants: a prospective comparison with the traditional palpation method. Anesthesiology. 1999 Jul;91(1):71-7. — View Citation

Walker SM. Neonatal pain. Paediatr Anaesth. 2014 Jan;24(1):39-48. doi: 10.1111/pan.12293. Epub 2013 Nov 13. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score difference	The patient pain score will be assessed prior to the procedure and during. The difference in pain score will be calculated as a representation of the increased pain inflicted by the procedure itself. This difference in pain scores will be compared across the 2 different interventions	Through study completion, around 7 months
Secondary	The number of first successful attempts	With each procedure the number of attempts will be registered for each procedure, comparing between the 2 different interventions the number of successful attempts from first trial.	Through study completion, around 7 months
Secondary	Number of total attempts	With each procedure the number of attempts will be registered for each procedure, the total number of trials will be compared between the 2 different interventions	Through study completion, around 7 months
Secondary	Procedure duration	The procedure duration is the time from the start of the procedure till successful insertion of the central catheter. The total procedural duration will be compared between the 2 different interventions	Through study completion, around 7 months