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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320916
• Other study ID #: 2010/191/SC
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: August 16, 2016
• Start date: April 2013
• Est. completion date: May 2013

Study information

• Verified date: August 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Gas Analysis
• Pain

Intervention

Procedure:
• 23Gauge
Arterial puncture will be made using a 23Gauge needle
• 25Gauge
Arterial puncture will be made using a 25Gauge needle

Locations

Country	Name	City	State
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No