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
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Jet injection lidocaine
J-Tip jet injection of 1% buffered lidocaine
干预措施: J-Tip jet injector (Device)
Jet injection saline
J-Tip jet injection of sterile saline
干预措施: Jet injection saline (Device)
Lidocaine cream
Lidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture
干预措施: lidocaine cream (Drug)
结局指标
主要结局
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
时间窗: 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
次要结局
- The success of venipuncture or PIVC insertion with all anesthetic techniques(30 minutes)
- Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores(30 minutes)
- Variety of locations of successful venipuncture or PIVC insertion after jet injection use(30 minutes)
- Measurement of complication rate after jet injection use(1 hour)
- 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)