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NCT00125255 · ClinicalTrials.gov registry record · Phase 3
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children
A Phase 3 study, sponsored by ZARS Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 81
- Enrollment target
NCT00125255: Completed Phase 3 study, sponsored by ZARS Pharma.
NCT00125255 is a Phase 3 study that has completed, run by ZARS Pharma. The registered enrollment target is 81 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00125255, a Phase 3 study, has completed, sponsored by ZARS Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 81 participants
- Enrollment target
Study Summary
The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects as well as the length of time necessary to provide adequate anesthesia. Recent guidelines strongly advocate for the proactive treatment of pain in children, including the pain associated with medical procedures. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate whether S-Caine Peel is effective in providing topical local dermal anesthesia prior to a vascular access procedure in children 5 through 17 years of age.
Primary Outcome
The primary efficacy variable was pain intensity as reported by the patient using the Colored Analog Scale (CAS) (scale 0 to 10), a validated tool for measuring pain in children.
Interventions
- DRUG S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
- DRUG Placebo Peel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2005-06 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
What the finished NCT00125255 record still lists
NCT00125255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) is the first listed.
NCT00125255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00125255 about?
NCT00125255 is a clinical study titled "S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children". The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects as well...
What is the current status of trial NCT00125255?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 81 participants. The study started on 2005-06. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00125255?
The interventions under investigation include: S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%) (DRUG), Placebo Peel (DRUG).
Who is sponsoring clinical trial NCT00125255?
This trial is sponsored by ZARS Pharma, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00125255's enrollment target sits among peer trials
81 1752nd of 2000 higher than 246 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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