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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02320916
Other study ID # 2010/191/SC
Secondary ID
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


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
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