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

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• At the discretion of the investigator, any subjects that may have to be withdrawn from the study