Status:
COMPLETED
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Vascular Access Procedures in Children
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Pain
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief 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. Reason...
Detailed Description
This was a randomized, double-blind, placebo-controlled, parallel study that evaluated the effectiveness of S-Caine Peel in providing local dermal anesthesia for vascular access procedures in children...
Eligibility Criteria
Inclusion
- Patient is 5 through 17 years of age.
- Patient has a medical indication to undergo a venous vascular access procedure (excluding peripherally inserted central catheter \[PICC\] lines) on the antecubital surface.
Exclusion
- Patient is pregnant or breastfeeding.
- Patient has participated in a clinical trial of an unapproved drug within the previous 30 days.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00125255
Start Date
June 1 2005
End Date
October 1 2005
Last Update
June 6 2012
Active Locations (1)
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1
Children's Hospital
Boston, Massachusetts, United States, 02115