Blood Sampling Through Peripheral Venous Catheter in Infants

• Conditions: Pain

• Registration Number: NCT01119911
• Lead Sponsor: Meir Medical Center

Brief Summary

We hypothesize that peripheral venous catheter used for fluid administration can replace venipuncture blood sampling for selected basic analytes and thus reduce pain in infants under 2 years of age.

Detailed Description

Multiple venipunctures in hospitalized children result in physical and emotional distress. Recently, we have found that blood sampling via peripheral venous catheter used for fluid administration in children significantly reduces pain and, except for glucose, can replace venipuncture for determining complete blood count and basic chemistry analytics, including white and red blood cell counts, hemoglobin and hematocrit levels, mean corpuscular volume, mean corpuscular hemoglobin level, red blood cell distribution width, platelet count, mean platelet volume, and sodium, potassium, chloride, and urea levels (Berger-Achituv S, Budde-Schwartzman B. Ellis MH, Shenkman Z. Erez I. Blood Sampling through Peripheral Venous Catheters for Selected Basic Analytes in Children. Pediatrics. In press).

The goal of this study is to investigate whether blood sampling via peripheral venous catheter used for fluid administration can significantly reduces pain and replace venipuncture for determining complete blood count and basic chemistry analytics in infants under 2 years of age.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-19
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Infants under 2 years of age.
• Only hemodynamically stable infants.
• Infants with peripheral venous catheter present for less than 72 hours.
• At least 20 mL of fluids have been infused intravenously at the time of blood sampling.

Exclusion Criteria

• Infants with signs of catheter-related thrombophlebitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices.	Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.	Comparisons of complete blood count (including white and red blood cells, hemoglobin, hematocrit, mean corpuscular volume and hemoglobin, red cell distribution width, platelets, mean platelet volume) and basic chemistry indices (including sodium, potassium, glucose, chloride, urea) will be performed and hemolysis will be documented.

Secondary Outcome Measures

Name	Time	Method
Assessment of infant's mood during procedures.	Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.	The investigator will record infant's mood (calm, distressed/crying, crying vigorously) during blood sampling from peripheral venous catheter and direct venipuncture.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel