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

Lee's Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Anesthesia, Local; Catheter Site Pain; Pain, Acute

Treatments: Drug: Lidocaine (Zingo); Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03653260

2016-ZK-007

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.

Enrollment: 288 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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• At the discretion of the investigator, any subjects that may have to be withdrawn from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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288 participants in 2 patient groups, including a placebo group

Lidocaine (Zingo)

Experimental group

Description:

0.5mg lidocaine at 20 bar pressure

Treatment:

Drug: Lidocaine (Zingo)

Placebo

Placebo Comparator group

Description:

no emitted particle at 20 bar pressure, identical in external appearance to Zingo

Treatment:

Drug: Placebo