Local Anesthesia Before Arterial Puncture for Blood Gas Analysis
NCT ID: NCT01964248
Last Updated: 2015-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2012-12-31
2015-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lidocaïne/prilocaïne
* Lidocaine/prilocaine eutectic mixture 5% incorporated in a cream base
* Single dose: 2 grams (one tube of cream)
* Cream applied 2 hours before blood sample
lidocaïne/prilocaïne 5%
Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample
Placebo
* Single dose: 2 grams (one tube of cream)
* Cream applied 2 hours before blood sample
Placebo
Placebo cream applied 2 hours before blood sample
Interventions
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Placebo
Placebo cream applied 2 hours before blood sample
lidocaïne/prilocaïne 5%
Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Francis COUTURAUD, Professor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Morvan, CHRU de Brest
Locations
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Monocentric study
Brest, , France
Countries
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References
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Beaumont M, Goret M, Orione C, Fauche A, Nowak E, Dion A, Darnois V, Tromeur C, Cogulet V, Leroyer C, Couturaud F, Le Mao R. Effect of Local Anesthesia on Pain During Arterial Puncture: The GAEL Randomized Placebo-Controlled Trial. Respir Care. 2021 Jun;66(6):976-982. doi: 10.4187/respcare.08328. Epub 2021 Mar 23.
Other Identifiers
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RB 12.011 (GAEL)
Identifier Type: -
Identifier Source: org_study_id
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