The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
288
0.5 mg lidocaine, 20 bar pressure
Placebo injector, 20 Bar pressure, empty injector
Shanghai Children's Medical Center
Shanghai, China
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.
Time frame: immediate after venipunture
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."
Time frame: immediate after venipunture
Response Rate
Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale
Time frame: immediate after venipunture
Compliance Score
Compliance to venipuncture assess by investigator
Time frame: immediate after venipunture
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