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

Not Applicable

Completed

• Conditions: Puncture Site Pain
• Interventions: Drug: Water spray; Drug: Vapocoolant spray

• Registration Number: NCT01860248
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-16
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water spray	Water spray	The Patients in this arm will receive water spray as anesthetic before ABG.
Vapocoolant spray	Vapocoolant spray	Vapocoolant is administered in 20 centimeters distance for 20 seconds to the patients as anesthetic before ABG.

Primary Outcome Measures

Name	Time	Method
puncture pain	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 Outcome Measures

Name	Time	Method
Vapocoolant application pain	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.
number of puncture attempts	30 seconds after procedure	The number of ABG sampling attempts is recorded 30 seconds after procedure.

Trial Locations

Locations (1)

Imam Khomeini hospital complex; 🇮🇷 Tehran, Iran, Islamic Republic of