Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

Phase 2

Completed

• Conditions: Pain
• Interventions: Device: Standard needle BBraun Sterican® 23G and 25mm in length; Device: Insulin

• Registration Number: NCT01996189
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-10-28
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-21
• Last Update Submitted: 2013-11-21
• Study First Posted: 2013-11-27
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin	Standard needle BBraun Sterican® 23G and 25mm in length	Arterial puncture with an insulin syringe followed by arterial puncture with standard needle.
Insulin	Insulin	Arterial puncture with an insulin syringe followed by arterial puncture with standard needle.
Standard	Standard needle BBraun Sterican® 23G and 25mm in length	Arterial puncture with standard needle followed by arterial puncture with insulin syringe.
Standard	Insulin	Arterial puncture with standard needle followed by arterial puncture with insulin syringe.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) score in millimetres	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

Name	Time	Method
blood haemolysis	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.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore