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| Name | Class |
|---|---|
| Zhaoke (Hefei) Pharmaceutical Limited | UNKNOWN |
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The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine (Zingo) | Experimental | 0.5mg lidocaine at 20 bar pressure |
|
| Placebo | Placebo Comparator | no emitted particle at 20 bar pressure, identical in external appearance to Zingo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine (Zingo) | Drug | 0.5 mg lidocaine, 20 bar pressure |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Frequency | 1 day | |
| Adverse Event Severity | 1 day | |
| Comfort of Zingo/Placebo Administration (Wong-Baker) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazhong Zhang, MD | Shanghai Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Medical Center | Shanghai | China |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | Placebo injector, 20 Bar pressure, empty injector |
|
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 |
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 |
| Aniline Compounds |
| D000588 | Amines |