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CompletedNCT02320916Updated Aug 17, 2016

A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced During Arterial Puncture

An interventional study of 23Gauge and 25Gauge in Blood Gas Analysis and Pain, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-17.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Arterial blood-gas (ABG) measurements are the gold standard to evaluate pulmonary gas exchange. However, arterial punctures are more painful than venous punctures and, in ICU patients, cause greater anxiety than tracheal aspiration. The only technique that has been shown to effectively reduce pain during arterial punctures is the subcutaneous injection of lidocaine. However, this technique is more time consuming and is poorly used.

Topical anesthesia is widely used during arterial punctures despite the lack of proof of efficacy.

While performing arterial punctures with small gauge needles is feasible, to the best of the investigators knowledge no studies have assessed the effect of needle gauge on arterial puncture related pain.

The aim of the present study was to compare the pain experienced during arterial punctures performed with a 25 G or 23 G needle. The secondary endpoints were the characterization of the pain and the anxiety associated with the arterial punctures.

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Conditions studied

  • Blood Gas Analysis
  • Pain
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In context

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients who had a planned assessment of arterial blood gas in our Respiratory Department

Exclusion criteria

Exclusion Criteria:

  • under the age of 18
  • inability to provide consent
  • the presence of a contraindication to arterial punctures based on the American Association of Respiratory Care Guidelines
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    23Gauge

    Arterial blood puncture will be performed using a 23Gauge needle

    Procedure: 23Gauge

  • Active comparator
    25Gauge

    Arterial blood puncture will be performed using a 25Gauge needle

    Procedure: 25Gauge

Interventions

  • Procedure23Gauge

    Arterial puncture will be made using a 23Gauge needle

  • Procedure25Gauge

    Arterial puncture will be made using a 25Gauge needle

06

What researchers measure

Primary outcomes

  1. Pain experienced by the patient during arterial puncture

    Evaluated using a Visual Analogue Scale for pain. Graduated from 0 to 100mm

    Time frame: Less thant 60minutes after puncture

Secondary outcomes

  1. Anxiety before and after puncture arterial puncture

    Evaluated using a Visual Analogue Scale for anxiety. Graduated from 0 to 100mm

    Time frame: Before puncture and less than 60minutes after puncture

  2. Most painful moment of the arterial puncture

    Evaluated by a standardised questionnaire: The most painful moment was : A/ At needle insertion B/ During puncture C/ After puncture D/ While the puncture was repeated

    Time frame: Less than 60minutes after puncture

  3. Duration of arterial puncture

    Time needed to perform the procedure will be evaluated using a chronometer. The number of seconds needed to collect the arterial blood gas will we recorded.

    Time frame: 10minutes

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Study locations

1 site
  • CHU de Rouen
    Rouen, 76000, France
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References and documents

Publications

  • Patout M, Lamia B, Lhuillier E, Molano LC, Viacroze C, Benhamou D, Muir JF, Cuvelier A. A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture. PLoS One. 2015 Sep 25;10(9):e0139432. doi: 10.1371/journal.pone.0139432. eCollection 2015. PubMed 26407017 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02320916
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Dec 19, 2014
Start date
Apr 2013
Primary completion
May 2013
Completion
May 2013
Last update
Aug 17, 2016

Study contacts

Bouchra Lamia, MD, MPH, PhD
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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