ACTRN12618001645246
Completed
未知
A safety and exploratory efficacy pilot study of NeedleCalm™ in reducing pain and needle sensation in a venepuncture procedure: a single group, single-blinded, randomised placebo-controlled investigation in healthy volunteers.
eedlecalm Pty Ltd0 sites12 target enrollmentOctober 4, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eedlecalm Pty Ltd
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Participants between 18 and 60 years of age at time of entry on study;
- •2\)Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment;
- •3\)Participants agree to undergo a venepuncture procedure once per procedure in the cubital fossa of the dominant arm and have 5 ml of blood collected; (i.e 10ml of blood will be collected).
- •4\)Participants agree to adhere to the study protocol;
- •5\)No history of illicit intravenous drug use;
- •6\)No history of needle\-phobia (trypanophobia);
- •7\)No history of any chronic diseases.
Exclusion Criteria
- •1\)Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, medical history, clinical chemistry, haematology, urinalysis, vital signs;
- •2\)Current or previous allergies or allergic responses to latex;
- •3\)Current use of any intravenously administered, prescribed or illicit drugs;
- •4\)Any history of moderate to severe needle\-phobia (trypanophobia);
- •5\)Pregnant or nursing an infant;
- •6\)Any psychiatric disorders by history or examination that would prevent completion of the venepuncture procedure or result in possible adverse events for the participant;
- •7\)The current use of any prescribed or over the counter analgesia (7 days wash\-out period required);
- •8\)Not have received more than two needle procedures in the past 12 months.
Outcomes
Primary Outcomes
Not specified
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