J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion
- Conditions
- Pain
- Interventions
- Registration Number
- NCT00924963
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Jet injection lidocaine J-Tip jet injector J-Tip jet injection of 1% buffered lidocaine Jet injection saline Jet injection saline J-Tip jet injection of sterile saline Lidocaine cream lidocaine cream Lidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture
- Primary Outcome Measures
Name Time Method 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 30 minutes 1. Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus 4% lidocaine topical cream
- Secondary Outcome Measures
Name Time Method The success of venipuncture or PIVC insertion with all anesthetic techniques 30 minutes Compare all types of anesthetics during venipuncture or PIVC
Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores 30 minutes compare pain scores across groups if a second attempt was made using VAS scores
Variety of locations of successful venipuncture or PIVC insertion after jet injection use 30 minutes compare successful venipunctures across locations
Measurement of complication rate after jet injection use 1 hour Compare variability of complications that arise post injection across groups
Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies 30 minutes Pain associated with venipuncture or PIVC insertion after pre-treatment with jet injection of 1% buffered lidocaine versus jet injection of sterile saline
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Liberty Township Emergency Department
🇺🇸Liberty Township, Ohio, United States