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

Pain, Acute Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653260
• Other study ID #: 2016-ZK-007
• Status: Completed
• Phase: Phase 3
• Start date: August 15, 2018
• Est. completion date: May 21, 2019

Study information

• Verified date: September 2019
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: May 21, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia, Local
• Catheter Site Pain
• Pain, Acute

Intervention

Drug:
• Lidocaine (Zingo)
0.5 mg lidocaine, 20 bar pressure
• Placebo
Placebo injector, 20 Bar pressure, empty injector

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited	Zhaoke (Hefei) Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Event Frequency		1 day
Other	Adverse Event Severity		1 day
Other	Comfort of Zingo/Placebo Administration (Wong-Baker)	Subject (all ages) to assess the level of comfort of Zingo/Placebo administration, measured using the Wong-Baker FACES scale (0-10), where 0 represent No Discomfort and 10 represent Worst Possible Discomfort.	immediate after venipunture
Other	Comfort of Zingo/Placebo Administration (VAS)	Subject (age 8-12) to assess the level of comfort of Zingo/Placebo administration, measured using VAS pain rating scales (0-100), where 0 represent No Discomfort and 100 represent Worst Possible Discomfort.	immediate after venipunture
Other	Local Adverse Reaction	Local Adverse Reactions including erythema, edema, pruritus and hemorrhage/petechiae by severity.	Pre-dose (0-1 hour before), immediately after dose, 15 minutes, 30 minutes
Primary	Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation	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.	immediate after venipunture
Secondary	100-mm Visual Analogue Scale (VAS)	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."	immediate after venipunture
Secondary	Response Rate	Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale	immediate after venipunture
Secondary	Compliance Score	Compliance to venipuncture assess by investigator	immediate after venipunture