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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00233844
Other study ID # III UV 82/03
Secondary ID
Status Completed
Phase Phase 2
First received October 5, 2005
Last updated October 5, 2005
Start date February 2004

Study information

Verified date October 2005
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at peripheral venipuncture


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

1. Male volunteers aged 20-40 years, height 165-190 cm.

2. Physical status I according to American Society of Anesthesiologists (ASA) classification.

3. Straight run of the vein on the dorsum of the non-dominant hand at least 4 cm long and 3 mm thick

4. No analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol

Exclusion Criteria:

1. History of peripheral neuropathy

2. Abnormal skin conditions (infection, scars, psoriasis, eczema)

3. Unsuccessful venipuncture

4. Inflamed site of VP within 1 week after VP

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Venipuncture with "cough-trick"


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medicine Greifswald

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity measured on VAS-100 scale
Secondary Heart rate, arterial pressure, hand withdrawal, sweating
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