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

• Status: Completed
• Trial end date: 2019-05-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Collaborator: Zhaoke (Hefei) Pharmaceutical Limited
• Treatments: Lidocaine

Criteria

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• At the discretion of the investigator, any subjects that may have to be withdrawn from the study