Back to resultsVapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial
Primary Purpose
Puncture Site Pain
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vapocoolant spray
Water spray
Sponsored by
About this trial
This is an interventional treatment trial for Puncture Site Pain focused on measuring vapocoolant effectiveness, arterial puncture
Eligibility Criteria
Inclusion Criteria:
- age of 14 years or older,
- needs ABG as a part of their diagnosis
Exclusion Criteria:
- history of analgesic medication used within 24 hours of enrollment,
- any sign of decreased consciousness,
- history of skin hypersensitivity,
- inability to report a pain score,
- history of a known neurological problem that changes pain perception,
- history of cold related reactions (e.g. Raynaud's phenomenon, cold urticaria),
- abnormal Allen's test
Sites / Locations
- Imam Khomeini hospital complex
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vapocoolant spray
Water spray
Arm Description
Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG.
The Patients in this arm will receive water spray as anesthetic before ABG.
Outcomes
Primary Outcome Measures
puncture pain
30 seconds after ABG was performed, the patients would be asked about the puncture pain in verbal numerical pain scale.
Secondary Outcome Measures
Vapocoolant application pain
30 seconds after ABG was performed, the patients would be asked about the spray application pain in verbal numerical pain scale.
number of puncture attempts
The number of ABG sampling attempts is recorded 30 seconds after procedure.
Full Information
NCT ID
NCT01860248
First Posted
May 7, 2013
Last Updated
July 16, 2013
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01860248
Brief Title
Vapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial
Official Title
Topical Alkane Vapocoolant Spray Effectiveness On Arterial Puncture Pain Reduction In Emergency Department: Randomized Double Blind Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.
Detailed Description
Previous studies of vapocoolant sprays for reducing pain were mainly on venopuncture with inconsistent results. There was only one prospective open labeled controlled study on arterial blood gas sampling with ethyl chloride which did not show effectiveness. This study will assess the efficacy and tolerability of a topical alkane vapocoolant spray for arterial puncture in adults in comparison to control spray.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Puncture Site Pain
Keywords
vapocoolant effectiveness, arterial puncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vapocoolant spray
Arm Type
Experimental
Arm Description
Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG.
Arm Title
Water spray
Arm Type
Placebo Comparator
Arm Description
The Patients in this arm will receive water spray as anesthetic before ABG.
Intervention Type
Drug
Intervention Name(s)
Vapocoolant spray
Other Intervention Name(s)
Cryoanesthetic
Intervention Description
The Vapocoolant spray containing alkane is applied for 20 seconds.
Intervention Type
Drug
Intervention Name(s)
Water spray
Intervention Description
This spray is covered so the patient and the investigator can not find the spray type out.
Primary Outcome Measure Information:
Title
puncture pain
Description
30 seconds after ABG was performed, the patients would be asked about the puncture pain in verbal numerical pain scale.
Time Frame
30 seconds after ABG
Secondary Outcome Measure Information:
Title
Vapocoolant application pain
Description
30 seconds after ABG was performed, the patients would be asked about the spray application pain in verbal numerical pain scale.
Time Frame
30 seconds affter procedure completion
Title
number of puncture attempts
Description
The number of ABG sampling attempts is recorded 30 seconds after procedure.
Time Frame
30 seconds after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age of 14 years or older,
needs ABG as a part of their diagnosis
Exclusion Criteria:
history of analgesic medication used within 24 hours of enrollment,
any sign of decreased consciousness,
history of skin hypersensitivity,
inability to report a pain score,
history of a known neurological problem that changes pain perception,
history of cold related reactions (e.g. Raynaud's phenomenon, cold urticaria),
abnormal Allen's test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shervin Farahmand, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Khomeini hospital complex
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Vapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial
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