Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

NCT01996189 | Completed Phase 2

• 1 other identifier: JPFF-11-1-YYW
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• blood haemolysis

  Immediately after collection

Study Arms (2)

Insulin

EXPERIMENTAL

Arterial puncture with an insulin syringe followed by arterial puncture with standard needle.

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

Standard

ACTIVE COMPARATOR

Arterial puncture with standard needle followed by arterial puncture with insulin syringe.

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

Interventions

Standard needle BBraun Sterican® 23G and 25mm in length DEVICE

Arterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe.

Insulin; Standard

Insulin DEVICE

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

Insulin; Standard

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age above 21

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Pain

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Irwani Ibrahim, MBBS

  National Unversity Health Systems

  PRINCIPAL INVESTIGATOR

• Yau Ying Wei, MBBS

  National University Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 27, 2013
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

SG (1)