DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: J-Tip jet injector (Device); Jet injection saline (Device); lidocaine cream (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Children's Hospital Medical Center, Cincinnati

Official(s) and/or principal investigator(s):
Stephanie L Spanos, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Srikant Iyer, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati

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.

Clinical Details

Official title: Comparison of J-Tip Jet Injection of 1% Buffered Lidocaine, 4% Lidocaine Topical Cream, and J-Tip Jet Injection of Placebo Prior to Venipuncture and Peripheral Intravenous Catheter Insertion in a Pediatric Emergency Department

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Jet injection of 1% buffered lidocaine to 4% lidocaine topical cream to measure the effectiveness of jet injection of lidocaine as a local anesthetic prior to venipuncture and PIVC insertion

Secondary outcome:

Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies

Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores

The success of venipuncture or PIVC insertion with all anesthetic techniques

Variety of locations of successful venipuncture or PIVC insertion after jet injection use

Measurement of complication rate after jet injection use

Eligibility

Minimum age: 7 Years. Maximum age: 21 Years. Gender(s): Both.

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.

Locations and Contacts

Cincinnati Children's Hospital Liberty Township Emergency Department, Liberty Township, Ohio 45044, United States
Additional Information

Starting date: June 2009
Last updated: October 17, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017