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

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Pain, Acute; Catheter Site Pain
• Intervention / Treatment: Drug: Lidocaine (Zingo); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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• At the discretion of the investigator, any subjects that may have to be withdrawn from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Frequency		1 day
Adverse Event Severity		1 day
Comfort of Zingo/Placebo Administration (Wong-Baker)	Subject (all ages) to assess the level of comfort of Zingo/Placebo administration, measured using the Wong-Baker FACES scale (0-10), where 0 represent No Discomfort and 10 represent Worst Possible Discomfort.	immediate after venipunture
Comfort of Zingo/Placebo Administration (VAS)	Subject (age 8-12) to assess the level of comfort of Zingo/Placebo administration, measured using VAS pain rating scales (0-100), where 0 represent No Discomfort and 100 represent Worst Possible Discomfort.	immediate after venipunture
Local Adverse Reaction	Local Adverse Reactions including erythema, edema, pruritus and hemorrhage/petechiae by severity.	Pre-dose (0-1 hour before), immediately after dose, 15 minutes, 30 minutes

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Collaborators: Zhaoke (Hefei) Pharmaceutical Limited
• Investigators: Principal Investigator: Mazhong Zhang, MD, Shanghai Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): May 21, 2019

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2016-ZK-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No