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Less Pain in Neonates During Central Lines Insertion

NCT03647293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-08-27

No results posted yet for this study

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

Interventions

PROCEDURE

Ultrasound Guided Central Catheter Insertion

PROCEDURE

Peripherally Inserted Central Catheter

Sponsors & Collaborators

  • Saint George Hospital

    lead OTHER

Principal Investigators

  • Dany Al Hamod, MD · Saint Georges Hospital University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03647293 on ClinicalTrials.gov