Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients
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| First Received Date ICMJE | August 13, 2012 | ||||||||
| Last Updated Date | October 20, 2012 | ||||||||
| Start Date ICMJE | October 2012 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain score on the visual analog scale [ Time Frame: <1 minute after stream device application, , 1 minute after intravenous catheter placement. ] [ Designated as safety issue: No ] Numeric rating scale (VAS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01670487 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
satisfaction of patient and health care provider. [ Time Frame: Within one hour of intravenous cannulation. ] [ Designated as safety issue: No ] Questionnaire for both the patient and the healthcare provider to be completed after the intravenous cannulation. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients | ||||||||
| Official Title ICMJE | Prospective,Randomized,Blinded, Comparative,Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Intravenous Cannulation in Emergency Department Patients. | ||||||||
| Brief Summary | To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in decreasing the pain of intravenous cannulation. To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water) stream. |
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| Detailed Description | Vapocoolant sprays have been used to decrease the pain associated with painful medical procedures such as immunizations, needle aspirations, injections, venipuncture and intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a painful injection and does affect the success rate of the procedure including intravenous cannulation and may even increase the success rate of the intravenous cannulation. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01670487 | ||||||||
| Other Study ID Numbers ICMJE | GEB-02 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Sharon Mace, The Cleveland Clinic | ||||||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||||||
| Collaborators ICMJE | Gebauer Company | ||||||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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