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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Experimental | Patients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion |
|
| Placebo | Placebo Comparator | Patients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Pain's evaluation for Remifentanil Group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion | up to 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of patient's anxiety by the Face Anxiety Scale | up to 60 minutes | |
| Patient and physician's satisfaction by a 10-points numeric rating scale | up to 60 minutes | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean RUIZ, MD, PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094935 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
CVC pain's evaluation after local anesthesia + placebo infusion |
|
| Number of adverse events |
| up to 60 minutes |
| Number of realized punctions | up to 60 minutes |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |