PainPhase 3NCT02221024
Normal Saline Flushes at 12 vs 24 Hours Intervals for Maintaining Peripheral Intravenous Catheters Patency
A Phase 3 study testing Flushing with positive pressure, Normal saline and MicroClave ICU Medica in people with Pain, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Children admitted in a ward often require a peripheral intravenous catheter to provide access for administration of medications, nutrients, fluids, blood products. Vascular access in children is a frequent and stressful procedure that should be performed as infrequently as possible in order to reduce the child's pain… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pain
- What is being tested?
- Flushing with positive pressure, Normal saline and MicroClave ICU Medica
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Sep 2013
- Phase
- Phase 3
- 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 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 1 and 17 years
- peripheral intravenous catheter 22 G or 24 G
- need to maintain the access for at least 24 hours without infusion
Who cannot join
- need for continuous infusion therapy
- programmed therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
About this study
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency
Children admitted in a ward often require a peripheral intravenous catheter to provide access for administration of medications, nutrients, fluids, blood products. Vascular access in children is a frequent and stressful procedure that should be performed as infrequently as possible in order to reduce the child's pain experience and the child's and family's level of distress. The maintenance of patency of indwelling catheters is therefore relevant to minimize need for replacement and children discomfort.
Recent studies investigated the most effective and safe method of maintaining peripheral intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the use of heparin versus saline flushes, showing similar efficacy of the two approaches.
To the best of the investigators knowledge no study addressed the issue of the optimal flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of normal saline flushes, at 12 and 24 hours intervals.
- Conditions
- Pain
- Being tested
- Flushing with positive pressure, Normal saline, MicroClave ICU Medica
- Keywords
- Peripheral intravenous catheter, Peripheral intravenous lock, Normal saline, Patency, Management, of peripheral, intravenous catheter
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flushing with positive pressureProcedure or surgery
Placement of a sterile plug (MicroClave ICU Medica, a neutral displacement connector) on the needle cannula and flushing with positive pressure with saline solution (BD PosiFlush XS Syringes, filled with 3 ml of saline)
Normal salineDrug
Also called Isotonic saline solution, Physiological saline solution
MicroClave ICU MedicaDevice
| Study group | Role | What they receive |
|---|---|---|
| Flushing every 24 hours | Experimental | Flushing with positive pressure with normal saline every 24 hours Receives: Procedure: Flushing with positive pressure; Drug: Normal saline; Device: MicroClave ICU Medica |
| Flushing every 12 hours | Active comparator | Flushing with positive pressure with normal saline every 12 hours Receives: Procedure: Flushing with positive pressure; Drug: Normal saline; Device: MicroClave ICU Medica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with peripheral intravenous catheter patency
Patency was defined as the possibility of flushing the cannula with a 3 ml Becton Dickinson syringe filled with 3 ml of normal saline in less than 20 seconds without resistance at infusion, pain or erythema
Measured: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Secondary outcomes (4)
Number of participants with blood extravasation
Presence of blood extravasation in the site of catheter insertion, defined as the presence of changes in the site's appearence and temperature (i.e. edema, blanching, coolness) at the time of nurse's evaluation
Measured: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Number of participants with pain
Any pain at the site of catheter insertion referred by patients to nurses
Measured: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Number of participants with skin redness
Presence of skin redness at the site of catheter insertion at the time of nurse's evaluation
Measured: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Number of participants with swelling
Presence of swelling in the site of catheter insertion at the time of nurse's evaluation
Measured: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJul 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Egidio Barbi, MD, Study chair, IRCCS Burlo Garofolo, Trieste, ItalySilvana Schreiber, RN, Study director, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221024
- Sponsor's protocol ID
- RC 10/11
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schreiber S, Zanchi C, Ronfani L, Delise A, Corbelli A, Bortoluzzi R, Taddio A, Barbi E. Normal saline flushes performed once daily maintain peripheral intravenous catheter patency: a randomised controlled trial. Arch Dis Child. 2015 Jul;100(7):700-3. doi: 10.1136/archdischild-2014-307478. Epub 2015 Jan 14.
PubMed 25589559
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Efficacy of Normal Saline Flushes at 12 and 24 Hours Intervals in Maintaining Peripheral Intravenous Catheters Patency
- ClinicalTrials.gov ID
- NCT02221024
- Acronym / sponsor ID
- RC 10/11
- Conditions
- Pain
- Keywords
- Peripheral intravenous catheter, Peripheral intravenous lock, Normal saline, Patency, Management, of peripheral, intravenous catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Aug 2014 (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.
Children admitted in a ward often require a peripheral intravenous catheter to provide access for administration of medications, nutrients, fluids, blood products. Vascular access in children is a frequent and stressful procedure that should be performed as infrequently as possible in order to reduce the child's pain experience and the child's and family's level of distress. The maintenance of patency of indwelling catheters is therefore relevant to minimize need for replacement and children discomfort.
Recent studies investigated the most effective and safe method of maintaining peripheral intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the use of heparin versus saline flushes, showing similar efficacy of the two approaches.
To the best of the investigators knowledge no study addressed the issue of the optimal flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of normal saline flushes, at 12 and 24 hours intervals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flushing every 24 hours | Experimental | Procedure: Flushing with positive pressure, Drug: Normal saline, Device: MicroClave ICU MedicaFlushing with positive pressure with normal saline every 24 hours |
| Flushing every 12 hours | Active comparator | Procedure: Flushing with positive pressure, Drug: Normal saline, Device: MicroClave ICU MedicaFlushing with positive pressure with normal saline every 12 hours |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 1 and 17 years
- peripheral intravenous catheter 22 G or 24 G
- need to maintain the access for at least 24 hours without infusion
Key exclusion criteria (2 listed)
- need for continuous infusion therapy
- programmed therapy
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 |
|---|---|---|
| Flushing with positive pressurePlacement of a sterile plug (MicroClave ICU Medica, a neutral displacement connector) on the needle cannula and flushing with positive pressure with saline solution (BD PosiFlush XS Syringes, filled with 3 ml of saline) | Procedure or surgery | Flushing every 12 hours, Flushing every 24 hours |
| Normal salineAlso: Isotonic saline solution, Physiological saline solution | Drug | Flushing every 12 hours, Flushing every 24 hours |
| MicroClave ICU Medica | Device | Flushing every 12 hours, Flushing every 24 hours |
Primary outcome
Number of participants with peripheral intravenous catheter patency
Time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Patency was defined as the possibility of flushing the cannula with a 3 ml Becton Dickinson syringe filled with 3 ml of normal saline in less than 20 seconds without resistance at infusion, pain or erythema
4 secondary outcomes
Number of participants with blood extravasation
Time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Number of participants with pain
Time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Number of participants with skin redness
Time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Number of participants with swelling
Time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Derived from this study: PubMed 25589559Schreiber S, Zanchi C, Ronfani L, Delise A, Corbelli A, Bortoluzzi R, Taddio A, Barbi E. Normal saline flushes performed once daily maintain peripheral intravenous catheter patency: a randomised controlled trial. Arch Dis Child. 2015 Jul;100(7):700-3. doi: 10.1136/archdischild-2014-307478. Epub 2015 Jan 14.
Related trials for Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
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.
Egidio Barbi, MD study chair
IRCCS Burlo Garofolo, Trieste, Italy
Silvana Schreiber, RN study director
IRCCS Burlo Garofolo, Trieste, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flushing with positive pressure, Normal saline and MicroClave ICU Medica in people with Pain, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 20 Aug 2014. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with peripheral intravenous catheter patency (time frame: Until catheter use (i.e. drug infusion) or removal (catether related complication or no further need of use), with an expected avarage of 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221024, which also lists 1 linked publication.
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 20 Aug 2014.