Vapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial

July 16, 2013 updated by: Tehran University of Medical Sciences

Topical Alkane Vapocoolant Spray Effectiveness On Arterial Puncture Pain Reduction In Emergency Department: Randomized Double Blind Placebo-Controlled Trial

This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vapocoolant spray
Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG.
Drug: Vapocoolant spray
The Vapocoolant spray containing alkane is applied for 20 seconds.
Other Names:
  • Cryoanesthetic
Placebo Comparator: Water spray
The Patients in this arm will receive water spray as anesthetic before ABG.
Drug: Water spray
This spray is covered so the patient and the investigator can not find the spray type out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
puncture pain
Time Frame: 30 seconds after ABG
30 seconds after ABG was performed, the patients would be asked about the puncture pain in verbal numerical pain scale.
30 seconds after ABG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vapocoolant application pain
Time Frame: 30 seconds affter procedure completion
30 seconds after ABG was performed, the patients would be asked about the spray application pain in verbal numerical pain scale.
30 seconds affter procedure completion
number of puncture attempts
Time Frame: 30 seconds after procedure
The number of ABG sampling attempts is recorded 30 seconds after procedure.
30 seconds after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Shervin Farahmand, M.D., Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 16, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUMS 4341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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