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

August 16, 2016 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • CHU de ROUEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 23Gauge
Arterial blood puncture will be performed using a 23Gauge needle
Procedure: 23Gauge
Arterial puncture will be made using a 23Gauge needle
ACTIVE_COMPARATOR: 25Gauge
Arterial blood puncture will be performed using a 25Gauge needle
Procedure: 25Gauge
Arterial puncture will be made using a 25Gauge needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Less thant 60minutes after puncture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before puncture and less than 60minutes after puncture
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
Less than 60minutes after puncture
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.
10minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Bouchra Lamia, MD, MPH, PhD, University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (ESTIMATE)

December 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2010/191/SC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe