PainPhase 2NCT01996189
Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe
A Phase 2 study testing Standard needle BBraun Sterican® 23G and 25mm in length and Insulin in people with Pain, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The primary objective is to compare the difference in the pain score in radial arterial puncture using the insulin needle versus the standard 23G hypodermic needle. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Standard needle BBraun Sterican® 23G and 25mm in length and Insulin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- May 2012to Mar 2013
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age above 21
Who cannot join
- concurrent antipyretic use in the last 24 hrs,
- presence of painful conditions eg fracture, rheumatoid arthritis
- history of peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study
The primary objective is to compare the difference in the pain score in radial arterial puncture using the insulin needle versus the standard 23G hypodermic needle.
Read the detailed description
In a randomised, crossover design, healthy volunteers were recruited to receive bilateral radial arterial punctures. They were assigned to receive either the insulin or the standard needle as the first puncture using block randomisation. The primary outcome was the pain score measured on a 100mm visual analogue scale (VAS) and the secondary outcomes were procedural complications and rate of haemolysis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard needle BBraun Sterican® 23G and 25mm in lengthDevice
Arterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe.
InsulinDevice
Arterial puncture using the insulin syringe (Terumo®- 0.5 ml with attached needle 29G and 13mm in length)
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Experimental | Arterial puncture with an insulin syringe followed by arterial puncture with standard needle. Receives: Device: Standard needle BBraun Sterican® 23G and 25mm in length; Device: Insulin |
| Standard | Active comparator | Arterial puncture with standard needle followed by arterial puncture with insulin syringe. Receives: Device: Standard needle BBraun Sterican® 23G and 25mm in length; Device: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) score in millimetres
Immediately following the radial arterial punctures the outcome assessor asked the volunteer to assess the discomfort that was caused by the puncture. The volunteer was asked to place a slash on a 100 mm VAS sheet. The VAS showed "no pain" at 0 mm and "worst pain" at 100 mm.
Measured: Immediately after each puncture ( average within 5 minutes)
Secondary outcomes (1)
blood haemolysis
The serum collected during the punctures was analysed for the amount of free haemoglobin. We define presence of haemolysis as free haemoglobin concentration of more than 100 mg/dL.
Measured: Immediately after collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
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.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emergency, National University Hospital, Singapore
- Investigators
- Irwani Ibrahim, MBBS, Principal investigator, National Unversity Health SystemsYau Ying Wei, MBBS, Principal investigator, National University Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996189
- Sponsor's protocol ID
- JPFF-11-1-YYW
- Status last verified
- Nov 2013
- First submitted
- 28 Oct 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT01996189
- Acronym / sponsor ID
- JPFF-11-1-YYW
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Nov 2013 (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.
The primary objective is to compare the difference in the pain score in radial arterial puncture using the insulin needle versus the standard 23G hypodermic needle.
Detailed description
In a randomised, crossover design, healthy volunteers were recruited to receive bilateral radial arterial punctures. They were assigned to receive either the insulin or the standard needle as the first puncture using block randomisation. The primary outcome was the pain score measured on a 100mm visual analogue scale (VAS) and the secondary outcomes were procedural complications and rate of haemolysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Experimental | Device: Standard needle BBraun Sterican® 23G and 25mm in length, Device: InsulinArterial puncture with an insulin syringe followed by arterial puncture with standard needle. |
| Standard | Active comparator | Device: Standard needle BBraun Sterican® 23G and 25mm in length, Device: InsulinArterial puncture with standard needle followed by arterial puncture with insulin syringe. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age above 21
Key exclusion criteria (3 listed)
- concurrent antipyretic use in the last 24 hrs,
- presence of painful conditions eg fracture, rheumatoid arthritis
- history of peripheral vascular disease
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 |
|---|---|---|
| Standard needle BBraun Sterican® 23G and 25mm in lengthArterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe. | Device | Insulin, Standard |
| InsulinArterial puncture using the insulin syringe (Terumo®- 0.5 ml with attached needle 29G and 13mm in length) | Device | Insulin, Standard |
Primary outcome
Visual analogue scale (VAS) score in millimetres
Time frame: Immediately after each puncture ( average within 5 minutes)
Immediately following the radial arterial punctures the outcome assessor asked the volunteer to assess the discomfort that was caused by the puncture. The volunteer was asked to place a slash on a 100 mm VAS sheet. The VAS showed "no pain" at 0 mm and "worst pain" at 100 mm.
1 secondary outcome
blood haemolysis
Time frame: Immediately after collection
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 27 Nov 2013.
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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.
Irwani Ibrahim, MBBS principal investigator
National Unversity Health Systems
Yau Ying Wei, MBBS principal investigator
National University Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard needle BBraun Sterican® 23G and 25mm in length and Insulin in people with Pain, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 3 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 27 Nov 2013. 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 Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Visual analogue scale (VAS) score in millimetres (time frame: Immediately after each puncture ( average within 5 minutes)). 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 27 Nov 2013.