Clinical trial NCT00924963: J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Pain of venipuncture or IV insertion
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: 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
timeFrame: 30 minutes
Secondary outcomes:
measure: Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies
timeFrame: 30 minutes
measure: Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores
timeFrame: 30 minutes
measure: The success of venipuncture or PIVC insertion with all anesthetic techniques
timeFrame: 30 minutes
measure: Variety of locations of successful venipuncture or PIVC insertion after jet injection use
timeFrame: 30 minutes
measure: Measurement of complication rate after jet injection use
timeFrame: 1 hour
Other outcomes:
Locations:
city: Liberty Township
country: United States
facility: Cincinnati Children's Hospital Liberty Township Emergency Department
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephanie L Spanos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Srikant Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References: