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• Status: Withdrawn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.