Anesthesia, Local, Catheter Site Pain, Pain, Acute
Conditions
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.
Interventions
DRUGLidocaine (Zingo)
0.5 mg lidocaine, 20 bar pressure
DRUGPlacebo
Placebo injector, 20 Bar pressure, empty injector
Sponsors
Zhaoke (Hefei) Pharmaceutical Limited
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes
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enrolled in a Zingo clinical trial before * At the discretion of the investigator, any subjects that may have to be withdrawn from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation | 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
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | immediate after venipunture | Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale |
| Compliance Score | immediate after venipunture | Compliance to venipuncture assess by investigator |
| 100-mm Visual Analogue Scale (VAS) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Severity | 1 day | — |
| Comfort of Zingo/Placebo Administration (Wong-Baker) | 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) | 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 | 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. |
| Adverse Event Frequency | 1 day | — |
Countries
China
Outcome results
None listed