Catheter Site PainPhase 3NCT03653260
A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children
A Phase 3 study testing Lidocaine (Zingo) in people with Catheter Site Pain and Pain, Acute, run by Lee's Pharmaceutical Limited at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheter Site Pain, Pain, Acute, Anesthesia, Local
- What is being tested?
- Lidocaine (Zingo)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2018to 21 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children
The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.
- Conditions
- Catheter Site Pain, Pain, Acute, Anesthesia, Local
- Being tested
- Lidocaine (Zingo), Placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (Zingo)Drug
Also called Zingo
0.5 mg lidocaine, 20 bar pressure
PlaceboDrug
Placebo injector, 20 Bar pressure, empty injector
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine (Zingo) | Experimental | 0.5mg lidocaine at 20 bar pressure Receives: Drug: Lidocaine (Zingo) |
| Placebo | Placebo comparator | no emitted particle at 20 bar pressure, identical in external appearance to Zingo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate after venipunture
Secondary outcomes (3)
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."
Measured: immediate after venipunture
Response Rate
Percentage of subject who score 0 or 1 in the FACES Pain Rating Scale
Measured: immediate after venipunture
Compliance Score
Compliance to venipuncture assess by investigator
Measured: immediate after venipunture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start15 Aug 2018
- Primary completion28 Feb 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Site PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhaoke (Hefei) Pharmaceutical Limited
- Responsible party
- Sponsor
- Investigators
- Mazhong Zhang, MD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653260
- Sponsor's protocol ID
- 2016-ZK-007
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety in Chinese Children
- ClinicalTrials.gov ID
- NCT03653260
- Acronym / sponsor ID
- 2016-ZK-007
- Conditions
- Catheter Site Pain, Pain, Acute, Anesthesia, Local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Zhaoke (Hefei) Pharmaceutical Limited
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of Zingo in treating pain associated with venipunture and peripheral venous cannulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine (Zingo) | Experimental | Drug: Lidocaine (Zingo)0.5mg lidocaine at 20 bar pressure |
| Placebo | Placebo comparator | Drug: Placebono emitted particle at 20 bar pressure, identical in external appearance to Zingo |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine (Zingo)Also: Zingo0.5 mg lidocaine, 20 bar pressure | Drug | Lidocaine (Zingo) |
| PlaceboPlacebo injector, 20 Bar pressure, empty injector | Drug | Placebo |
Primary outcome
Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation
Time frame: 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.
3 secondary outcomes
100-mm Visual Analogue Scale (VAS)
Time frame: immediate after venipunture
Response Rate
Time frame: immediate after venipunture
Compliance Score
Time frame: immediate after venipunture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazhong Zhang, MD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine (Zingo) in people with Catheter Site Pain and Pain, Acute, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation (time frame: immediate after venipunture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.