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Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters

Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Local Anesthesia

Intervention: Remifentanil (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Toulouse

Official(s) and/or principal investigator(s):
Jean RUIZ, MD, PhD, Principal Investigator, Affiliation: CHU Toulouse

Overall contact:
Jean RUIZ, MD, PhD, Phone: 05 61 77 97 92, Ext: +33, Email: ruiz.jean@chu-toulouse.fr

Summary

At present, there is no reference protocol for Central Venous Catheter (CVC) insertion assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and anesthesia to realize this gesture, from single local anesthesia to general anesthesia. Remifentanil has been shown to decrease pain scores for insertion and removal of long-term central venous access. Remifentanil is also often employed for pediatric or labor analgesia for short acts as procedural sedation.

Clinical Details

Official title: REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion

Secondary outcome:

Evaluation of patient's anxiety by the Face Anxiety Scale

Patient and physician's satisfaction by a 10-points numeric rating scale

Number of adverse events

Number of realized punctions

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- more than 18 years old

- eligible for CVC insertion

Exclusion Criteria:

- pregnancy

- patients who can't give their consent

- contra-indications to remifentanil infusion

Locations and Contacts

Jean RUIZ, MD, PhD, Phone: 05 61 77 97 92, Ext: +33, Email: ruiz.jean@chu-toulouse.fr

University Hospital of Toulouse, Toulouse 31059, France; Recruiting
Jean RUIZ, MD PhD, Principal Investigator
BĂ©atrice RIU, Md, PhD, Sub-Investigator
Vincent MINVILLE, MD, PhD, Sub-Investigator
Elodie BRUNEL, MD, PhD, Sub-Investigator
Michel OLIVIER, MD, PhD, Sub-Investigator
Additional Information

Starting date: August 2014
Last updated: August 20, 2015

Page last updated: August 23, 2015

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