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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Device: J-Tip jet injector; Device: Jet injection saline; Drug: 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).

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jet injection lidocaine; J-Tip jet injection of 1% buffered lidocaine	Device: J-Tip jet injector; 0.2ml 1%buffered lidocaine delivered by jet injector; Other Names: J-Tip jet injector with 1% buffered lidocaine
Placebo Comparator: Jet injection saline; J-Tip jet injection of sterile saline	Device: Jet injection saline; 0.2ml saline delivered via J-Tip jet injection; Other Names: J-Tip Jet injection with saline
Active Comparator: Lidocaine cream; Lidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture	Drug: lidocaine cream; 4% lidocaine cream applied for 30 minutes to the skin; Other Names: 4% lidocaine cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The success of venipuncture or PIVC insertion with all anesthetic techniques	Compare all types of anesthetics during venipuncture or PIVC	30 minutes
Variety of locations of successful venipuncture or PIVC insertion after jet injection use	compare successful venipunctures across locations	30 minutes
Measurement of complication rate after jet injection use	Compare variability of complications that arise post injection across groups	1 hour

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Stephanie L Spanos, MD, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Srikant Iyer, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (Estimate): June 19, 2009

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Pain of venipuncture or IV insertion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2008-0922