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Arterial Puncture Using Insulin Syringe is Less Painful Than Standard Syringe

NCT ID: NCT01996189

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Insulin

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Insulin

Intervention Type DEVICE

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

Standard

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Insulin

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Insulin

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Emergency

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irwani Ibrahim, MBBS

Role: PRINCIPAL_INVESTIGATOR

National Unversity Health Systems

Yau Ying Wei, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Health Systems

Locations

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National University Hospital

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Other Identifiers

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JPFF-11-1-YYW

Identifier Type: -

Identifier Source: org_study_id