Clinical trial NCT03653260: A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Catheter Site Pain
Pain, Acute
Anesthesia, Local
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
Collaborators: name: Zhaoke (Hefei) Pharmaceutical Limited
First posted: 2018-08-31
Enrollment: 288
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* At the discretion of the investigator, any subjects that may have to be withdrawn from the study

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation
timeFrame: immediate after venipunture
Secondary outcomes:
measure: 100-mm Visual Analogue Scale (VAS)
timeFrame: immediate after venipunture
measure: Response Rate
timeFrame: immediate after venipunture
measure: Compliance Score
timeFrame: immediate after venipunture
Other outcomes:
measure: Adverse Event Frequency
timeFrame: 1 day
measure: Adverse Event Severity
timeFrame: 1 day
measure: Comfort of Zingo/Placebo Administration (Wong-Baker)
timeFrame: immediate after venipunture
measure: Comfort of Zingo/Placebo Administration (VAS)
timeFrame: immediate after venipunture
measure: Local Adverse Reaction
timeFrame: Pre-dose (0-1 hour before), immediately after dose, 15 minutes, 30 minutes
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
Study officials:
affiliation: Shanghai Children's Medical Center
name: Mazhong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: