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

NCT02320916 | Completed

• 1 other identifier: 2010/191/SC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Gas Analysis; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anxiety before and after puncture arterial puncture

  Before puncture and less than 60minutes after puncture

• Most painful moment of the arterial puncture

  Less than 60minutes after puncture

• Duration of arterial puncture

  10minutes

Study Arms (2)

23Gauge

ACTIVE COMPARATOR

Arterial blood puncture will be performed using a 23Gauge needle

Procedure: 23Gauge

25Gauge

ACTIVE COMPARATOR

Arterial blood puncture will be performed using a 25Gauge needle

Procedure: 25Gauge

Interventions

23Gauge PROCEDURE

Arterial puncture will be made using a 23Gauge needle

23Gauge

25Gauge PROCEDURE

Arterial puncture will be made using a 25Gauge needle

25Gauge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de Rouen

Rouen, 76000, France

Location

Related Publications (1)

• Patout M, Lamia B, Lhuillier E, Molano LC, Viacroze C, Benhamou D, Muir JF, Cuvelier A. A Randomized Controlled Trial on the Effect of Needle Gauge on the Pain and Anxiety Experienced during Radial Arterial Puncture. PLoS One. 2015 Sep 25;10(9):e0139432. doi: 10.1371/journal.pone.0139432. eCollection 2015.

  PMID: 26407017 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bouchra Lamia, MD, MPH, PhD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 19, 2014
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

FR (1)