Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening
Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening (PSF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Tel-Aviv, Israel, 64239
- Recruiting
- Emergency Department- Tel-Aviv Sourasky Medical Center
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Principal Investigator:
- Tatiana Levit, MD
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Sub-Investigator:
- Pinchas Halpern, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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VAS pain scaling differences between saline injection with PSF and without PSF
Time Frame: Immediately after each injection
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Immediately after each injection
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pinchas Halpern, MD, Tel-Aviv Sourasky Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TASMC 07- TL -268 CTIL
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