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

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Gas Analysis, Pain

Intervention / Treatment
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* Procedure: 23Gauge
* Procedure: 25Gauge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 23Gauge<br>Arterial blood puncture will be performed using a 23Gauge needle | Procedure: 23Gauge<br>* Arterial puncture will be made using a 23Gauge needle<br>|
| Active Comparator: 25Gauge<br>Arterial blood puncture will be performed using a 25Gauge needle | Procedure: 25Gauge<br>* Arterial puncture will be made using a 25Gauge needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain experienced by the patient during arterial puncture | Evaluated using a Visual Analogue Scale for pain. Graduated from 0 to 100mm | Less thant 60minutes after puncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety before and after puncture arterial puncture | Evaluated using a Visual Analogue Scale for anxiety. Graduated from 0 to 100mm | Before puncture and less than 60minutes after puncture | 
| 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 | Less than 60minutes after puncture | 
| 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. | 10minutes |