drugset / Trial / NCT06354816
VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults
Phase 4
Completed
40 enrolled
Lukas Hefler
Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern · collab
RandomizedCrossoverDouble-blindTreatment
Summary
Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC.
Timeline
- Start
- 2024-05-07
- Primary completion
- 2024-05-22
- Completion
- 2024-05-22
Outcome
Missed primary endpoint
registry Hand: Vessel at the Dorsum Manus - Placebo vs Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA; p = 0.398 NCT06354816 ↗
registry Forearm/Cubita - Placebo vs Forearm/Cubita - Lidocaine 10% LA; p = 0.550 NCT06354816 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 50 mg | Topical |
Indications
No indication recorded.