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OpenTrials
Completed

NCT Number: NCT02206022

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

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.

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Key information

Conditions

Local Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

Pain's evaluation for Remifentanil Group

Placebo

Drug

CVC pain's evaluation after local anesthesia + placebo infusion

Primary outcomes

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

    Time frame: up to 60 minutes

Secondary outcomes

  1. Evaluation of patient's anxiety by the Face Anxiety Scale

    Time frame: up to 60 minutes

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

    Time frame: up to 60 minutes

  3. Number of adverse events

    Time frame: up to 60 minutes

  4. Number of realized punctions

    Time frame: up to 60 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: REMIDOLCATH

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2014
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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