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

Phase 3

Completed

• Conditions: Catheter Site Pain; Pain, Acute; Anesthesia, Local
• Interventions: Drug: Lidocaine (Zingo); Drug: Placebo

• Registration Number: NCT03653260
• Lead Sponsor: Lee's Pharmaceutical Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Primary Completion: 2019-02-28
• Study Completion: 2019-05-21
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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• At the discretion of the investigator, any subjects that may have to be withdrawn from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine (Zingo)	Lidocaine (Zingo)	0.5mg lidocaine at 20 bar pressure
Placebo	Placebo	no emitted particle at 20 bar pressure, identical in external appearance to Zingo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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."
Compliance Score	immediate after venipunture	Compliance to venipuncture assess by investigator
Response Rate	immediate after venipunture	Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, China