A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children

Conditions
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Catheter Site Pain, Pain, Acute, Anesthesia, Local

Intervention / Treatment
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* Drug: Lidocaine (Zingo)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 3-12 About to undergo venipuncture or peripheral venous cannulation at the back of the hand or antecubital fossa Have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES scale (age 3-12) and the extremes of pain on a 100 mm visual analog scale (VAS) (ages 8-12) Signed informed consent, cooperative and agree to attend follow-up visits Exclusion Criteria: Any medical condition, non-compliance or instability (including but not limited to exceptionally upset, crying, anxiety) that in the judgement of the investigator might adversely affect the conduct of the study Used any (including external or inhaled) sedatives, analgesics, anaesthetics or other agents/device that may affect the efficacy assessment Subjects with tattoos, surgical scars, ports, implantable devices or a skin condition (e.g. excessive body hair) that may have interfered with the placement of Zingo or skin site assessments Active local infection or other skin pathology at the site of venipuncture or peripheral venous cannulation. Venipuncture of peripheral venous cannulation at the proposed site within the prior two weeks (longer if the wound is apparent) Previous history of allergic reactions to any local anaesthetic or tape/adhesive dressing. Participated in a clinical trial within three months prior to administration of study drug, or have already enrolled in a Zingo clinical trial before At the discretion of the investigator, any subjects that may have to be withdrawn from the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine (Zingo)<br>0.5mg lidocaine at 20 bar pressure | Drug: Lidocaine (Zingo)<br>* 0.5 mg lidocaine, 20 bar pressure<br>* Other names: Zingo;|
| Placebo Comparator: Placebo<br>no emitted particle at 20 bar pressure, identical in external appearance to Zingo | Drug: Placebo<br>* Placebo injector, 20 Bar pressure, empty injector<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation | Child's assessment of pain on venipuncture or peripheral venous cannulation (all ages) performed one to three minutes after Zingo/Placebo administration, measured using the Wong-Baker FACES pain rating scale. The scale includes pictures of facial expressions with correlating numerical scale of 0-10, 0 being no hurt and 10 being the worst hurt. | immediate after venipunture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100-mm Visual Analogue Scale (VAS) | Assessment of pain on venipuncture or peripheral venous cannulation by children age 8-12, measured using a 100-mm VAS (0-100) anchored at 0 for no pain and at 100 for worst possible pain. | immediate after venipunture | 
| Response Rate | Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale | immediate after venipunture | 
| Compliance Score | Compliance to venipuncture assess by investigator | immediate after venipunture |