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Completed

NCT Number: NCT01964248

Local Anesthesia Before Arterial Puncture for Blood Gas Analysis

The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Monocentric study

Brest, France

About this study

In an approach of continuous improvement of the quality of the care, this project joins logically after a reflection on the treatment of pain generated by the care in the department of Pneumology 1 / septic Thoracic and vascular Cardiac Surgery.

The arterial puncture for blood gas analysis is an act with aim diagnosis which allows to study gases of the arterial blood to watch the hematosis of the patient. This act appears at the top of the anticipated care as painful by the nursing teams.

In the literature, we find no study carried out with the eutectic mixture lidocaïne prilocaïne. Other local anesthetics and other local ways of administration were estimated and the results diverge as for the efficiency of a local anesthetic for the arterial blood sample at the level radial nerve. Finally authors showed a correlation between certain factors(mailmen) and the painful character of the arterial blood sample, without defining really of population.

In this context, it is necessary to estimate the interest of a local anesthetic before arterial sampling of blood by a study randomized in insu double and versus placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged more than 18 years old, having signed an enlightened consent, who have an indication of gazometry by taking radial nerve
  • Patients capable of estimating the pain felt with numeric pain intensity scale
  • Patients with numeric pain intensity scale = 0 before sample of blood
  • Patients with no contraindication or no allergy of an anesthetic such as lidocaine

Exclusion criteria

  • Patients aged less than 18 years old
  • Patients incapable of estimating the pain felt with numeric pain intensity scale
  • Patients with numeric pain intensity scale > 0 before sample of blood
  • Patients for whom the arterial taking is impossible for the level radial nerve
  • Hypersensibility to local anesthetics of the amide-type or other component of lidocaïne/prilocaïne cream
  • Porphyries known
  • Pregnant woman

Treatment and study plan

Placebo

Drug

Placebo cream applied 2 hours before blood sample

Other names: Application placebo cream 2 hours before blood sample

lidocaïne/prilocaïne 5%

Drug

Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample

Primary outcomes

  1. interest of local anesthesia (lidocaïne/prilocaïne)

    Time frame: 1 hour

    Determine the interest of local anesthesia with association of lidocaïne/prilocaïne before arteriel puncture for gas analysis

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study

Acronym: GAEL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2013
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.