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LMX4 for Venipuncture Pain in Pediatric Patients
NCT00676364Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2003
- Primary completion
- Feb 2008
- Countries
- 1
- Modality
- Transdermal Patches, Hydrogel Systems, Small Molecules
- Drugs
- LMX 4
- Conditions
- procedural painProcedural anxiety
01
Overview
Phase 4, randomised, double-blind trial in procedural pain and Procedural anxiety comparing LMX4 with Placebo (2 arms). Primary endpoint: Pain From Venipuncture. Started Mar 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
LMX4
4% lidocaine topical anesthetic cream applied for 15 minutes
Placebo
Matching placebo cream applied for 15 minutes
03
Who it enrols
Children aged 5-18 years requiring venipuncture, excluding those with allergies to amide anesthetics, G6PD deficiency, methemoglobinemia, cognitive impairment, or active skin conditions at the site.
04
Endpoints
Primary
Pain From Venipuncture
Secondary
Anxiety of Venipuncture
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