Less Pain in Neonates During Central Lines Insertion

NCT03647293 | Completed

• 1 other identifier: IRB/O/036-16/1916
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Central Venous Catheter; Neonates; Pain

Keywords

Central Catheter; Central Line; Internal Jugular Vein; Neonate; Peripherally Inserted Central Line; Ultrasound Guided; Pain Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The number of first successful attempts

  Through study completion, around 7 months

• Number of total attempts

  Through study completion, around 7 months

• Procedure duration

  Through study completion, around 7 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Neonates who underwent a peripherally inserted central catheter

Procedure: Peripherally Inserted Central Catheter

Intervention Group

ACTIVE COMPARATOR

Neonates who underwent an Ultrasound Guided Central Catheter Insertion

Procedure: Ultrasound Guided Central Catheter Insertion

Interventions

Ultrasound Guided Central Catheter Insertion PROCEDURE

Intervention Group

Peripherally Inserted Central Catheter PROCEDURE

Control Group

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• neonates requiring TPN
• antibiotic therapy for at least 7 days
• babies with poor or difficult venous access

You may not qualify if:

• refusal to sign consent
• patients with previously attempted or placed central lines
• patients who were converted from one technique to the other

Sponsors & Collaborators

• Saint George Hospital: lead

Related Publications (15)

• 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.

  PMID: 22368674 BACKGROUND

• Cheung E, Baerlocher MO, Asch M, Myers A. Venous access: a practical review for 2009. Can Fam Physician. 2009 May;55(5):494-6. No abstract available.

  PMID: 19439704 BACKGROUND

• Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.

  PMID: 17414086 BACKGROUND

• 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.

  BACKGROUND

• Kumar A, Chuan A. Ultrasound guided vascular access: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):299-311. doi: 10.1016/j.bpa.2009.02.006.

  PMID: 19862889 BACKGROUND

• 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. doi: 10.1136/bmj.327.7411.361.

  PMID: 12919984 BACKGROUND

• 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. doi: 10.1097/00003246-199612000-00020.

  PMID: 8968276 BACKGROUND

• 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. doi: 10.1097/00000542-199907000-00013.

  PMID: 10422930 BACKGROUND

• 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.

  PMID: 26168162 BACKGROUND

• 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.

  PMID: 27298814 BACKGROUND

• Pettit J. Technological advances for PICC placement and management. Adv Neonatal Care. 2007 Jun;7(3):122-31. doi: 10.1097/01.anc.0000278210.18639.fd.

  PMID: 17844776 BACKGROUND

• 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. doi: 10.1542/peds.2006-2277.

  PMID: 17079598 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23972757 BACKGROUND

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

  PMID: 24330444 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Dany Al Hamod, MD

  Saint Georges Hospital University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pediatrics, Head of the Post-Graduate Medical Education Office

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 27, 2018
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 27, 2018

Record last verified: 2018-08