A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children
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|ClinicalTrials.gov Identifier: NCT03653260|
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Catheter Site Pain Pain, Acute Anesthesia, Local||Drug: Lidocaine (Zingo) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
Placebo injector, 20 Bar pressure, empty injector
- 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.
- 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."
- Response Rate [ Time Frame: immediate after venipunture ]Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale
- Compliance Score [ Time Frame: immediate after venipunture ]Compliance to venipuncture assess by investigator
- Adverse Event Frequency [ Time Frame: 1 day ]
- Adverse Event Severity [ Time Frame: 1 day ]
- 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.
- 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.
- 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.
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
|Shanghai Children's Medical Center|
|Principal Investigator:||Mazhong Zhang, MD||Shanghai Children's Medical Center|