Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Standard needle BBraun Sterican® 23G and 25mm in length; Device: Insulin

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: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after each puncture ( average within 5 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after collection

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Investigators: Principal Investigator: Irwani Ibrahim, MBBS, National Unversity Health Systems; Principal Investigator: Yau Ying Wei, MBBS, National University Health Systems

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: JPFF-11-1-YYW