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

NCT03653260 | Completed Phase 3

• 1 other identifier: 2016-ZK-007
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Site Pain; Pain, Acute; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 100-mm Visual Analogue Scale (VAS)

  immediate after venipunture

• Response Rate

  immediate after venipunture

• Compliance Score

  immediate after venipunture

Other Outcomes (5)

• Adverse Event Frequency

  1 day

• Adverse Event Severity

  1 day

• Comfort of Zingo/Placebo Administration (Wong-Baker)

  immediate after venipunture

Study Arms (2)

Lidocaine (Zingo)

EXPERIMENTAL

0.5mg lidocaine at 20 bar pressure

Drug: Lidocaine (Zingo)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lidocaine (Zingo) DRUG

0.5 mg lidocaine, 20 bar pressure

Also known as: Zingo

Lidocaine (Zingo)

Placebo DRUG

Placebo injector, 20 Bar pressure, empty injector

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• Zhaoke (Hefei) Pharmaceutical Limited: collaborator

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mazhong Zhang, MD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: August 15, 2018
• Primary Completion: February 28, 2019
• Study Completion: May 21, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)