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

Phase 4CompletedNCT02206022

University Hospital, Toulouse90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Local Anesthesia

Interventions

RemifentanilDRUG

Pain's evaluation for Remifentanil Group

PlaceboDRUG

CVC pain's evaluation after local anesthesia + placebo infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

University Hospital of Toulouse

Toulouse, France

Outcomes

Primary Outcomes

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

Time frame: up to 60 minutes

Secondary Outcomes

Evaluation of patient's anxiety by the Face Anxiety Scale

Time frame: up to 60 minutes

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

Time frame: up to 60 minutes

Number of adverse events

Time frame: up to 60 minutes

Number of realized punctions

Time frame: up to 60 minutes

Data from ClinicalTrials.gov

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