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Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date November 27, 2013
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe
Official Title  ICMJE Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pain
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: Insulin
    Arterial puncture with an insulin syringe followed by arterial puncture with standard needle.
    Interventions:
    • Device: Standard needle BBraun Sterican® 23G and 25mm in length
    • Device: Insulin
  • Active Comparator: Standard
    Arterial puncture with standard needle followed by arterial puncture with insulin syringe.
    Interventions:
    • Device: Standard needle BBraun Sterican® 23G and 25mm in length
    • Device: Insulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01996189
Other Study ID Numbers  ICMJE JPFF-11-1-YYW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emergency, National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Irwani Ibrahim, MBBS National Unversity Health Systems
Principal Investigator: Yau Ying Wei, MBBS National University Health Systems
PRS Account National University Hospital, Singapore
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP