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.

Not Applicable

Completed

• Conditions: iatrogenic pain associated with needle procedures; Anaesthesiology - Pain management

• Registration Number: ACTRN12618001645246
• Lead Sponsor: eedlecalm Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-04
• Study Completion: 2018-10-07
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified