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Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening

NCT00503087 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2007-08-08

No results posted yet for this study

Summary

Each participant will be administered 2 injections of saline - the first in the right gluteal area and the second in the left gluteal area. Both injections will be administered intra-muscularly by the same clinician. One injection will be given with vacuum (Pneumatic Skin Flattening or PSF Machine) and the other without vacuum. The order of the injections will be randomly assigned. Each subject will serve as a control for himself. Between injections a 30 min pause will be given to minimize pain sensation bias of the previous injection. Immediately after each injection the pain level will be assessed by the VAS scale. The researcher assessing the pain will be blinded for the type of injection given. The evaluation of the pain reduction will be made by comparison of the pain level with and without the application of the PSF.

Hypothesis: PSF Technique will reduce the pain associated with saline injections.

Conditions

  • Healthy

Interventions

PROCEDURE

Saline Injection

DEVICE

Pneumatic Skin Flattening (PSF)

Sponsors & Collaborators

  • PalJect Ltd.

    lead INDUSTRY

Principal Investigators

  • Pinchas Halpern, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Completion
2008-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00503087 on ClinicalTrials.gov