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

NCT ID: NCT01860248

Last Updated: 2013-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Puncture Site Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Vapocoolant spray

Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG.

Group Type EXPERIMENTAL

Vapocoolant spray

Intervention Type DRUG

The Vapocoolant spray containing alkane is applied for 20 seconds.

Water spray

The Patients in this arm will receive water spray as anesthetic before ABG.

Group Type PLACEBO_COMPARATOR

Water spray

Intervention Type DRUG

This spray is covered so the patient and the investigator can not find the spray type out.

Interventions

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Vapocoolant spray

The Vapocoolant spray containing alkane is applied for 20 seconds.

Intervention Type DRUG

Water spray

This spray is covered so the patient and the investigator can not find the spray type out.

Intervention Type DRUG

Other Intervention Names

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Cryoanesthetic

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shervin Farahmand, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Imam Khomeini hospital complex

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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TUMS 4341

Identifier Type: -

Identifier Source: org_study_id

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