Overview

J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion

Status:
Withdrawn
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
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 pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine, J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide superior local anesthesia compared to saline or lidocaine cream.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Treatments:
Lidocaine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.