PainNCT01119911
Blood Sampling Through Peripheral Venous Catheter in Infants
An observational study of Pain, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 1 week to 24 months
- Conditions the study is for
- Pain
- What is being tested?
- Blood sampling from peripheral venous catheter.
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: All infants under 2 years of age, admitted to the Departments of Pediatrics and Pediatric Surgery, Meir Medical Center, who have a functioning peripheral venous catheter and require repeated blood sampling for diagnostic purposes.
Who may be able to join
- 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.
Who cannot join
- Infants with signs of catheter-related thrombophlebitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Sampling Through Peripheral Venous Catheter for Selected Basic Analytes in Infants
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Blood sampling from peripheral venous catheter.
- Keywords
- Blood sampling, Venipuncture, Peripheral venous catheter, Complete blood count, Basic chemistry, Hemolysis, Peripheral venous catheter replaces venipuncture., Peripheral venous catheter blood sampling reduces pain.
- Medical subject headings
- Pain, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling from peripheral venous catheter.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.
Secondary outcomes (1)
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.
Measured: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sivan Berger-Achituv, MD, Principal investigator, Meir Medical CenterIlan Erez, Dr, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119911
- Sponsor's protocol ID
- MMC10086-09CTIL
- Status last verified
- Mar 2012
- First submitted
- 4 May 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Sampling Through Peripheral Venous Catheter for Selected Basic Analytes in Infants
- ClinicalTrials.gov ID
- NCT01119911
- Acronym / sponsor ID
- MMC10086-09CTIL
- Conditions
- Pain
- Keywords
- Blood sampling, Venipuncture, Peripheral venous catheter, Complete blood count, Basic chemistry, Hemolysis, Peripheral venous catheter replaces venipuncture., Peripheral venous catheter blood sampling reduces pain.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Study completion
- Jun 2012 (estimated)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 week to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All infants under 2 years of age, admitted to the Departments of Pediatrics and Pediatric Surgery, Meir Medical Center, who have a functioning peripheral venous catheter and require repeated blood sampling for diagnostic purposes.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants with signs of catheter-related thrombophlebitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices.
Time frame: 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.
1 secondary outcome
Assessment of infant's mood during procedures.
Time frame: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sivan Berger-Achituv, MD principal investigator
Meir Medical Center
Ilan Erez, Dr principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erez Ilan, MD (972-9-7472344, erezi@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the interchangeability of peripheral venous catheter and venipuncture for complete blood count and basic chemistry indices. (time frame: Primary assessment will be done after data analysis of the first 20 participants, estimated to take up to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.