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

Local Anesthesia Clinical Trial

— REMIDOLCATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206022
• Other study ID #: 13 6932 03
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

Drug:
• Remifentanil
Pain's evaluation for Remifentanil Group
• Placebo
CVC pain's evaluation after local anesthesia + placebo infusion

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion		up to 60 minutes
Secondary	Evaluation of patient's anxiety by the Face Anxiety Scale		up to 60 minutes
Secondary	Patient and physician's satisfaction by a 10-points numeric rating scale		up to 60 minutes
Secondary	Number of adverse events		up to 60 minutes
Secondary	Number of realized punctions		up to 60 minutes