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Completed

NCT Number: NCT02320916

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

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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Key information

Conditions

Blood Gas Analysis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rouen

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

23Gauge

Procedure

Arterial puncture will be made using a 23Gauge needle

25Gauge

Procedure

Arterial puncture will be made using a 25Gauge needle

Primary outcomes

  1. Pain experienced by the patient during arterial puncture

    Time frame: Less thant 60minutes after puncture

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

Secondary outcomes

  1. Anxiety before and after puncture arterial puncture

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

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

  2. Most painful moment of the arterial puncture

    Time frame: Less than 60minutes after 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

  3. Duration of arterial puncture

    Time frame: 10minutes

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 19, 2014
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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