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Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients

This study has been completed.
Sponsor:
Collaborator:
Gebauer Company
Information provided by (Responsible Party):
Sharon Mace, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01670487
First received: August 13, 2012
Last updated: July 29, 2016
Last verified: July 2016
Results First Received: February 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Pain
Interventions: Device: Vapocoolant
Device: Sterile water

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vapocoolant (Pain Ease Medium Stream)

Application of the stream steadily 4 to 10 seconds onto the cannulation site.

Vapocoolant: Topical stream of 4 to 10 seconds duration to skin

Nature's Tears

Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.

Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin.


Participant Flow:   Overall Study
    Vapocoolant (Pain Ease Medium Stream)     Nature's Tears  
STARTED     150     150  
COMPLETED     150     150  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
adults undergoing IV annulation in ED

Reporting Groups
  Description
Vapocoolant (Pain Ease Medium Stream) Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin
Nature's Tears Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin
Total Total of all reporting groups

Baseline Measures
    Vapocoolant (Pain Ease Medium Stream)     Nature's Tears     Total  
Number of Participants  
[units: participants]
  150     150     300  
Age  
[units: years]
Median (Inter-Quartile Range)
  52  
  (35 to 60)  
  50  
  (37 to 62)  
  51  
  (35 to 62)  
Gender  
[units: participants]
     
Female     94     64     158  
Male     56     86     142  



  Outcome Measures

1.  Primary:   Pain Score on the Numeric Rating Scale (NRS)   [ Time Frame: pain of intravenous catheter placement. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sharon Mace
Organization: Cleveland Clinic
phone: 216-445-4598
e-mail: maces@ccf.org


Publications:

Responsible Party: Sharon Mace, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01670487     History of Changes
Other Study ID Numbers: GEB-02
Study First Received: August 13, 2012
Results First Received: February 1, 2016
Last Updated: July 29, 2016
Health Authority: United States: Institutional Review Board