Status:
COMPLETED
Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation
Lead Sponsor:
Akron Children's Hospital
Conditions:
Pain
Eligibility:
All Genders
2-7 years
Phase:
PHASE4
Brief Summary
This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation ...
Eligibility Criteria
Inclusion
- scheduled for painless diagnostic procedures
- are ASA I or ASA II
Exclusion
- have an indwelling central venous catheter
- have received an analgesic or sedative medication in the previous four hours prior to enrollment
- have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
- known hypersensitivity to lidocaine or any component of the formulation
- hypersensitivity to another local anesthetic of the amide type
- Adam-Stokes syndrome
- severe degrees of SA, AV, or intraventricular heart block
- allergy to corn-related products
- contraindication to propofol
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00786916
Start Date
February 1 2008
End Date
January 1 2011
Last Update
February 27 2015
Active Locations (1)
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1
Akron Children's Hospital
Akron, Ohio, United States, 44308