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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02206022
Acronym
REMIDOLCATH
Enrollment
90
Registered
2014-08-01
Start date
2014-08-31
Completion date
2017-12-31
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia

Keywords

Central Venous Catheter, Remifentanil, local anesthesia, pain

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.

Interventions

DRUGRemifentanil

Pain's evaluation for Remifentanil Group

DRUGPlacebo

CVC pain's evaluation after local anesthesia + placebo infusion

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Maximal pain score on numeric rating scale (NRS) will be assessed after the insertionup to 60 minutes

Secondary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026