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

Primary Purpose

Catheter Site Pain, Pain, Acute, Anesthesia, Local

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Lidocaine (Zingo)

Placebo

About this trial

This is an interventional treatment trial for Catheter Site Pain

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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At the discretion of the investigator, any subjects that may have to be withdrawn from the study

Sites / Locations

Shanghai Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine (Zingo)

Placebo

Arm Description

0.5mg lidocaine at 20 bar pressure

no emitted particle at 20 bar pressure, identical in external appearance to Zingo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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."

Response Rate

Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale

Compliance Score

Compliance to venipuncture assess by investigator

Full Information

NCT ID

NCT03653260

First Posted

August 28, 2018

Last Updated

September 23, 2019

Sponsor

Lee's Pharmaceutical Limited

Collaborators

Zhaoke (Hefei) Pharmaceutical Limited

1. Study Identification

Unique Protocol Identification Number

NCT03653260

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

August 15, 2018 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

May 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lee's Pharmaceutical Limited

Collaborators

Zhaoke (Hefei) Pharmaceutical Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter Site Pain, Pain, Acute, Anesthesia, Local

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

288 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine (Zingo)

Arm Type

Experimental

Arm Description

0.5mg lidocaine at 20 bar pressure

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

no emitted particle at 20 bar pressure, identical in external appearance to Zingo

Intervention Type

Drug

Intervention Name(s)

Lidocaine (Zingo)

Other Intervention Name(s)

Zingo

Intervention Description

0.5 mg lidocaine, 20 bar pressure

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo injector, 20 Bar pressure, empty injector

Primary Outcome Measure Information:

Title

Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation

Description

Time Frame

immediate after venipunture

Secondary Outcome Measure Information:

Title

100-mm Visual Analogue Scale (VAS)

Description

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."

Time Frame

immediate after venipunture

Title

Response Rate

Description

Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale

Time Frame

immediate after venipunture

Title

Compliance Score

Description

Compliance to venipuncture assess by investigator

Time Frame

immediate after venipunture

Other Pre-specified Outcome Measures:

Title

Adverse Event Frequency

Time Frame

1 day

Title

Adverse Event Severity

Time Frame

1 day

Title

Comfort of Zingo/Placebo Administration (Wong-Baker)

Description

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.

Time Frame

immediate after venipunture

Title

Comfort of Zingo/Placebo Administration (VAS)

Description

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.

Time Frame

immediate after venipunture

Title

Local Adverse Reaction

Description

Local Adverse Reactions including erythema, edema, pruritus and hemorrhage/petechiae by severity.

Time Frame

Pre-dose (0-1 hour before), immediately after dose, 15 minutes, 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mazhong Zhang, MD

Organizational Affiliation

Shanghai Children's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Children's Medical Center

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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