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Completed

NCT Number: NCT01860248

Vapocoolant Spray Effectiveness On Arterial Puncture Pain: 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.

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Key information

Conditions

Puncture Site Pain

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imam Khomeini hospital complex

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vapocoolant spray

Drug

The Vapocoolant spray containing alkane is applied for 20 seconds.

Other names: Cryoanesthetic

Water spray

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. number of puncture attempts

    Time frame: 30 seconds after procedure

    The number of ABG sampling attempts is recorded 30 seconds after procedure.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 22, 2013
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.