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

NCT00503087 | Unknown Phase 1 DMC

• 1 other identifier: TASMC 07- TL -268 CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Injections; Vacuum; Pain; Pneumatic Skin Flattening; PSF

Outcome Measures

Primary Outcomes (1)

• VAS pain scaling differences between saline injection with PSF and without PSF

  Immediately after each injection

Interventions

Saline Injection PROCEDURE

Pneumatic Skin Flattening (PSF) DEVICE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients 18 years old or older
• Healthy
• Patient informed consent must be obtained

You may not qualify if:

• Pregnant or nursing women
• Patients unable to understand or sign the informed consent form
• Anticoagulant or aspirin treatment
• Subjects with a history of vaso-vagal reactions to injections
• Coagulopathies
• Skin disease
• Chronic usage of medication

Sponsors & Collaborators

• PalJect Ltd.: lead

Study Sites (1)

Emergency Department- Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (3)

• MELZACK R, WALL PD. On the nature of cutaneous sensory mechanisms. Brain. 1962 Jun;85:331-56. doi: 10.1093/brain/85.2.331. No abstract available.

  PMID: 14472486 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Lask G, Friedman D, Elman M, Fournier N, Shavit R, Slatkine M. Pneumatic skin flattening (PSF): a novel technology for marked pain reduction in hair removal with high energy density lasers and IPLs. J Cosmet Laser Ther. 2006 Jun;8(2):76-81. doi: 10.1080/14764170600719775.

  PMID: 16766485 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pinchas Halpern, MD

  Tel-Aviv Sourasky Medical Center

  STUDY DIRECTOR

Central Study Contacts

Pinchas Halpern, MD

CONTACT

+972-3-697-3829; dr_halperin@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 18, 2007
• Study Start: August 1, 2007
• Study Completion: July 1, 2008
• Last Updated: August 8, 2007

Record last verified: 2007-08

Locations

IL (1)