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

T

Tehran University of Medical Sciences

Status

Completed

Conditions

Puncture Site Pain

Treatments

Drug: Vapocoolant spray
Drug: Water spray

Study type

Interventional

Funder types

Other

Identifiers

NCT01860248
TUMS 4341

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

Vapocoolant spray
Experimental group
Description:
Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG.
Treatment:
Drug: Vapocoolant spray
Water spray
Placebo Comparator group
Description:
The Patients in this arm will receive water spray as anesthetic before ABG.
Treatment:
Drug: Water spray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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