NCT01860248

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 17, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

May 7, 2013

Last Update Submit

July 16, 2013

Conditions

Puncture Site Pain

Keywords

vapocoolant effectivenessarterial puncture

Outcome Measures

Primary Outcomes (1)

  • puncture pain

    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 Outcomes (2)

  • Vapocoolant application pain

    30 seconds affter procedure completion

  • number of puncture attempts

    30 seconds after procedure

Study Arms (2)

Vapocoolant spray

EXPERIMENTAL

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

Drug: Vapocoolant spray

Water spray

PLACEBO COMPARATOR

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

Drug: Water spray

Interventions

Vapocoolant sprayDRUG

The Vapocoolant spray containing alkane is applied for 20 seconds.

Also known as: Cryoanesthetic
Vapocoolant spray
Water sprayDRUG

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

Water spray

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age of 14 years or older,
  • needs ABG as a part of their diagnosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomeini hospital complex

Tehran, Tehran Province, Iran

Location

Study Officials

  • Shervin Farahmand, M.D.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 22, 2013

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 17, 2013

Record last verified: 2013-07

Locations

IR(1)