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

Study Overview
=================
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).

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: J-Tip jet injector
* Device: Jet injection saline
* Drug: lidocaine cream


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain of venipuncture or IV insertion