Status:
WITHDRAWN
J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Pain
Eligibility:
All Genders
7-21 years
Phase:
EARLY_PHASE1
Brief Summary
To measure and compare pain associated with venipuncture and peripheral intravenous catheter insertion among pediatric emergency department patients randomized to treatment with one of three different...
Detailed Description
Background: Venipuncture and PIVC insertion are the most common procedures performed in the pediatric emergency department. They are painful procedures, and frequently no local anesthesia is provided....
Eligibility Criteria
Inclusion
- Children aged seven to twenty-one years old requiring venipuncture or PIVC insertion as part of their emergency department care are eligible for the study.
Exclusion
- Lidocaine allergy,
- TegadermTM allergy,
- Glasgow Coma Score (GCS) less than 15,
- Pain at the proposed site for the procedure,
- Requirement of a PIVC or venipuncture immediately due to illness acuity,
- Inability to complete a self-reported pain scale (VAS, visual analogue scale),
- Patients who do not speak and understand English, OR
- Previous enrollment in the study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00924963
Start Date
June 1 2009
End Date
June 1 2010
Last Update
September 21 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Liberty Township Emergency Department
Liberty Township, Ohio, United States, 45044