A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children (NCT03653260) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Zingo in Chinese Children
China288 participantsStarted 2018-08-15
Plain-language 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.
Who can participate
Age range3 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 discr…
What they're measuring
1
Wong-Baker FACES Pain Rating Scale After Venipuncture or Peripheral Cannulation