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Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

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ClinicalTrials.gov Identifier: NCT01996189
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Emergency, National University Hospital, Singapore

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Device: Standard needle BBraun Sterican® 23G and 25mm in length Device: Insulin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study
Study Start Date : May 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin
Arterial puncture with an insulin syringe followed by arterial puncture with standard needle.
Device: Standard needle BBraun Sterican® 23G and 25mm in length
Arterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe.

Device: Insulin
Arterial puncture using the insulin syringe (Terumo®- 0.5 ml with attached needle 29G and 13mm in length)

Active Comparator: Standard
Arterial puncture with standard needle followed by arterial puncture with insulin syringe.
Device: Standard needle BBraun Sterican® 23G and 25mm in length
Arterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe.

Device: Insulin
Arterial puncture using the insulin syringe (Terumo®- 0.5 ml with attached needle 29G and 13mm in length)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. blood haemolysis [ Time Frame: Immediately after collection ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age above 21

Exclusion Criteria:

  • concurrent antipyretic use in the last 24 hrs,
  • presence of painful conditions eg fracture, rheumatoid arthritis
  • history of peripheral vascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996189


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Irwani Ibrahim, MBBS National Unversity Health Systems
Principal Investigator: Yau Ying Wei, MBBS National University Health Systems
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Responsible Party: Emergency, Doctor, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01996189    
Other Study ID Numbers: JPFF-11-1-YYW
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs