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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653260
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Zhaoke (Hefei) Pharmaceutical Limited
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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.

Condition or disease Intervention/treatment Phase
Catheter Site Pain Pain, Acute Anesthesia, Local Drug: Lidocaine (Zingo) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : May 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lidocaine (Zingo)
0.5mg lidocaine at 20 bar pressure
Drug: Lidocaine (Zingo)
0.5 mg lidocaine, 20 bar pressure
Other Name: 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




Primary Outcome Measures :
  1. Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation [ Time Frame: immediate after venipunture ]
    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 :
  1. 100-mm Visual Analogue Scale (VAS) [ Time Frame: immediate after venipunture ]
    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."

  2. Response Rate [ Time Frame: immediate after venipunture ]
    Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale

  3. Compliance Score [ Time Frame: immediate after venipunture ]
    Compliance to venipuncture assess by investigator


Other Outcome Measures:
  1. Adverse Event Frequency [ Time Frame: 1 day ]
  2. Adverse Event Severity [ Time Frame: 1 day ]
  3. Comfort of Zingo/Placebo Administration (Wong-Baker) [ Time Frame: immediate after venipunture ]
    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.

  4. Comfort of Zingo/Placebo Administration (VAS) [ Time Frame: immediate after venipunture ]
    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.

  5. Local Adverse Reaction [ Time Frame: Pre-dose (0-1 hour before), immediately after dose, 15 minutes, 30 minutes ]
    Local Adverse Reactions including erythema, edema, pruritus and hemorrhage/petechiae by severity.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653260


Locations
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China
Shanghai Children's Medical Center
Shanghai, China
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Zhaoke (Hefei) Pharmaceutical Limited
Investigators
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Principal Investigator: Mazhong Zhang, MD Shanghai Children's Medical Center

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03653260    
Other Study ID Numbers: 2016-ZK-007
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action