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

NCT ID: NCT02206022

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remifentanil

Patients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

Pain's evaluation for Remifentanil Group

Placebo

Patients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

CVC pain's evaluation after local anesthesia + placebo infusion

Interventions

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Remifentanil

Pain's evaluation for Remifentanil Group

Intervention Type DRUG

Placebo

CVC pain's evaluation after local anesthesia + placebo infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean RUIZ, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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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):691-695. doi: 10.1097/AJP.0000000000000725.

Reference Type RESULT
PMID: 31094935 (View on PubMed)

Other Identifiers

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13 6932 03

Identifier Type: -

Identifier Source: org_study_id

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