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

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00924963
• Other study ID #: 2008-0922
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. The American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine has recommended that local anesthesia be provided, but a variety of barriers exist which have prevented implementation of this recommendation.

Specific Aims: 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.

Methods: This study is a partially blinded, placebo controlled, randomized controlled clinical trial in the pediatric emergency department. The comparison of J-Tip® jet injection of 1% buffered lidocaine to J-Tip® jet injection of sterile saline is double blinded, while the comparison of jet injection to 4% lidocaine topical cream is not blinded. Forty-four patients per group will be enrolled, and a VAS self-reported measurement will be recorded for the pain of venipuncture or PIVC insertion following the appropriate treatment. As well, success of the procedure and complications of treatment will be recorded.

Results: Pain scores will be analyzed by pairwise comparisons using a t-test and pooled comparisons using ANOVA. Demographics will be assessed to determine baseline differences among the three groups. Chi square and regression analysis will be performed on demographic differences to determine significance if necessary. Final pain results will be reported as mean, standard deviation, and p-value. Demographics will be reported as number, percent of patients, and p-value (if a difference exists).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• J-Tip jet injector
0.2ml 1%buffered lidocaine delivered by jet injector
• Jet injection saline
0.2ml saline delivered via J-Tip jet injection

Drug:
• lidocaine cream
4% lidocaine cream applied for 30 minutes to the skin

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Liberty Township Emergency Department	Liberty Township	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1. Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus 4% lidocaine topical cream	30 minutes
Secondary	Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies	Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus jet injection of sterile saline	30 minutes
Secondary	Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores	compare pain scores across groups if a second attempt was made using VAS scores	30 minutes
Secondary	The success of venipuncture or PIVC insertion with all anesthetic techniques	Compare all types of anesthetics during venipuncture or PIVC	30 minutes
Secondary	Variety of locations of successful venipuncture or PIVC insertion after jet injection use	compare successful venipunctures across locations	30 minutes
Secondary	Measurement of complication rate after jet injection use	Compare variability of complications that arise post injection across groups	1 hour