Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

Pain Clinical Trial

Official title:

Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe, a Randomized Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996189
• Other study ID #: JPFF-11-1-YYW
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2013
• Last updated: November 21, 2013
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No