Pain
Conditions
Keywords
Pain of venipuncture or IV insertion
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).
Interventions
DEVICEJ-Tip jet injector
0.2ml 1%buffered lidocaine delivered by jet injector
DEVICEJet injection saline
0.2ml saline delivered via J-Tip jet injection
DRUGlidocaine cream
4% lidocaine cream applied for 30 minutes to the skin
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| The success of venipuncture or PIVC insertion with all anesthetic techniques | 30 minutes | Compare all types of anesthetics during venipuncture or PIVC |
| 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 |
Countries
United States
Outcome results
None listed