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Vapocoolant (Pain Ease) Use for Venipuncture

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ClinicalTrials.gov Identifier: NCT01712776
Recruitment Status : Completed
First Posted : October 24, 2012
Results First Posted : December 11, 2014
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Gebauer Company
Information provided by (Responsible Party):
Sharon Mace, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Device: Vapocoolant (Pain Ease)
Device: Nature's Tears Sterile Water
Enrollment 100
Recruitment Details emergency department patients
Pre-assignment Details  
Arm/Group Title Placebo (Normal Saline, Nature&Apos;s Tears) Vapocoolant (Pain Ease Medium Stream )
Hide Arm/Group Description

Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.

Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.

Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.

Period Title: Overall Study
Started 50 50
Completed 50 [1] 50
Not Completed 0 0
[1]
trial to enroll 50 in each group for total of 100
Arm/Group Title Vapocoolant (Pain Ease Medium Stream ) Nature's Tears Total
Hide Arm/Group Description

Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.

Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.

Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
pain after spray with placebo or vapocoolant
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
52.98  (13.42) 51.48  (11.48) 52.23  (12.45)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
31
  62.0%
23
  46.0%
54
  54.0%
Male
19
  38.0%
27
  54.0%
46
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
Hide Description NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)
Time Frame Less than 10 minutes after stream application.
Hide Outcome Measure Data
Hide Analysis Population Description
equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups
Arm/Group Title Vapocoolant (Pain Ease Medium Stream ) Nature's Tears
Hide Arm/Group Description:

Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.

Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.

Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.7  (2.3) 4.7  (2.9)
Time Frame 10 minutes
Adverse Event Reporting Description Time frame = the time the patients were in the emergency department Skin assessments were done within 10 minutes after spray application
 
Arm/Group Title Vapocoolant (Pain Ease Medium Stream ) Nature's Tears
Hide Arm/Group Description

Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.

Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin.

Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.

Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin.

All-Cause Mortality
Vapocoolant (Pain Ease Medium Stream ) Nature's Tears
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Vapocoolant (Pain Ease Medium Stream ) Nature's Tears
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vapocoolant (Pain Ease Medium Stream ) Nature's Tears
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      1/50 (2.00%)    
Skin and subcutaneous tissue disorders     
Skin felt cool  1 [1]  2/50 (4.00%)  2 1/50 (2.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, other
[1]
"skin felt cool" at 10 minutes no skin abnormalities seen
This study enrolled only adults. No pediatric patients were enrolled. However, an earlier study by Farion KJ et al in CMAJ in 2008 found that the use of a vapocoolant (pain-ease) significantly decreased the pain of intravenous cannulation in children
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sharon E. Mace, Director of Research, ESI
Organization: Cleveland Clinic
Phone: (216) 445-4598
EMail: maces@ccf.org
Layout table for additonal information
Responsible Party: Sharon Mace, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01712776    
Other Study ID Numbers: GEB-01
First Submitted: October 4, 2012
First Posted: October 24, 2012
Results First Submitted: January 9, 2014
Results First Posted: December 11, 2014
Last Update Posted: March 6, 2017