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

Phase 4
Completed
Conditions
Local Anesthesia
Interventions
Drug: Placebo
Registration Number
NCT02206022
Lead Sponsor
University Hospital, Toulouse
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RemifentanilRemifentanilPatients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion
PlaceboPlaceboPatients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion
Primary Outcome Measures
NameTimeMethod
Maximal pain score on numeric rating scale (NRS) will be assessed after the insertionup to 60 minutes
Secondary Outcome Measures
NameTimeMethod
Evaluation of patient's anxiety by the Face Anxiety Scaleup to 60 minutes
Patient and physician's satisfaction by a 10-points numeric rating scaleup to 60 minutes
Number of adverse eventsup to 60 minutes
Number of realized punctionsup to 60 minutes

Trial Locations

Locations (1)

University Hospital of Toulouse

🇫🇷

Toulouse, France

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