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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by PalJect Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
PalJect Ltd.
ClinicalTrials.gov Identifier:
NCT00503087
First received: July 17, 2007
Last updated: August 7, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Healthy
Procedure: Saline Injection
Device: Pneumatic Skin Flattening (PSF)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
Official Title: Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening (PSF)

Further study details as provided by PalJect Ltd.:

Primary Outcome Measures:
  • VAS pain scaling differences between saline injection with PSF and without PSF [ Time Frame: Immediately after each injection ]

Estimated Enrollment: 20
Study Start Date: August 2007
Estimated Study Completion Date: July 2008
Detailed Description:

Injections are currently the gold-standard for administrating various medications parenterally. The most significant side-effect related to injections is the accompanying pain. Injection pain is related to the penetration of the skin by the needle and to the mechanical and chemical effects of the drug during and after its injection. This pain remains a major obstacle in medication administration in children as well as in other populations subject to needle-phobia because of the pain experience. The associated pain may thus prevent optimized medical care for these patients.

Current methods to alleviate immediate pain include the utilization of topical anesthesia whereas some patients do not utilize any form of pain relief and simply endure the pain of the injection. Other methods for pain reduction are taking advantage of the applying pressure or vibration to alleviate pain. These methods have resulted in a number of pain relieving devices currently on the market. Such predicate devices primarily involve vibration devices commonly used to alleviate the injection pain. Published data suggests possible use of pressure application mechanism in pain alleviation related to injections.

We suggest here, for the first time, the use of the Pneumatic Skin Flattening (PSF) technology for alleviation of pain associated with injections. The PSF technology is currently used worldwide in the FDA cleared Serenity device (Serenity, Inolase Ltd.) for pain reduction in hair removal. The device generates contact and compression between a transparent sapphire window and the skin. The compression creatures pressure signal which, based on the gate theory, is though to depress the pain associated with the hair removal treatment. We assume the same mechanism would apply for the reduction of pain associated with injections.

Comparison: Intra-Subject pain level change of injection with PSF and without PSF

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503087

Contacts
Contact: Pinchas Halpern, MD +972-3-697-3829 dr_halperin@tasmc.health.gov.il

Locations
Israel
Emergency Department- Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Principal Investigator: Tatiana Levit, MD         
Sub-Investigator: Pinchas Halpern, MD         
Sponsors and Collaborators
PalJect Ltd.
Investigators
Study Director: Pinchas Halpern, MD Tel-Aviv Sourasky Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00503087     History of Changes
Other Study ID Numbers: TASMC 07- TL -268 CTIL
Study First Received: July 17, 2007
Last Updated: August 7, 2007
Health Authority: Israel: Ministry of Health

Keywords provided by PalJect Ltd.:
Injections
Vacuum
Pain
Pneumatic Skin Flattening
PSF

ClinicalTrials.gov processed this record on September 22, 2014