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

NCT ID: NCT00924963

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-06-30

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 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.

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. 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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Jet injection lidocaine

J-Tip jet injection of 1% buffered lidocaine

Group Type: EXPERIMENTAL

J-Tip jet injector

Intervention Type: DEVICE

0.2ml 1%buffered lidocaine delivered by jet injector

Jet injection saline

J-Tip jet injection of sterile saline

Group Type: PLACEBO_COMPARATOR

Jet injection saline

Intervention Type: DEVICE

0.2ml saline delivered via J-Tip jet injection

Lidocaine cream

Lidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture

Group Type: ACTIVE_COMPARATOR

lidocaine cream

Intervention Type: DRUG

4% lidocaine cream applied for 30 minutes to the skin

Interventions

J-Tip jet injector

0.2ml 1%buffered lidocaine delivered by jet injector

Intervention Type: DEVICE

Jet injection saline

0.2ml saline delivered via J-Tip jet injection

Intervention Type: DEVICE

lidocaine cream

4% lidocaine cream applied for 30 minutes to the skin

Intervention Type: DRUG

Other Intervention Names

J-Tip jet injector with 1% buffered lidocaine; J-Tip Jet injection with saline; 4% lidocaine cream

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie L Spanos, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Srikant Iyer, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Liberty Township Emergency Department

Liberty Township, Ohio, United States

Countries

United States

Other Identifiers

2008-0922

Identifier Type: -

Identifier Source: org_study_id