Blood Sampling Through Peripheral Venous Catheter in Infants

Pain Clinical Trial

Official title:

Blood Sampling Through Peripheral Venous Catheter for Selected Basic Analytes in Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01119911
• Other study ID #: MMC10086-09CTIL
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2010
• Last updated: March 16, 2012
• Start date: May 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Erez Ilan, MD
• Phone: 972-9-7472344
• Email: erezi[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Blood sampling from peripheral venous catheter.
Venipuncture is performed on the opposite limb of the peripheral venous catheter. Within 3 minutes, a second sample is taken from existing peripheral venous catheter used for fluid administration. Intravenous fluids are then stopped for 30 seconds and a tourniquet applied proximal to the device for another 30 seconds. A 2-mL syringe is attached and 0.5 mL of blood aspirated and discarded. Thereafter, 2 mL blood is slowly drawn during about 15 seconds, into a different 2-mL syringe, to allow a gentle pumping action that may reduce vacuum in the syringe and thus hemolysis rates. Afterwards, the intravenous device is flushed with 2 mL normal saline and infusion restarted.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices.	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.	Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.	No
Secondary	Assessment of infant's mood during procedures.	The investigator will record infant's mood (calm, distressed/crying, crying vigorously) during blood sampling from peripheral venous catheter and direct venipuncture.	Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.	No