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Study of Ice Application to Reduce Pain From Arterial Punctures

Primary Purpose

Vessel Puncture Site Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryotherapy (ice pack)
Sponsored by
St. Joseph Hospital, New Hampshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vessel Puncture Site Pain focused on measuring ice, cryotherapy, puncture, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • subjects ≥ 18 years old referred to the pulmonary function laboratory with a physician order for an arterial blood gas test were sought to complete the study

Exclusion Criteria:

  • cold, bluish hands and fingers
  • diagnosis of Raynaud's syndrome or scleroderma/CREST syndrome
  • history or signs of dementia, confusion, or cognitive impairment
  • blindness
  • patients not fluent in the English language
  • non-palpable radial pulse in the wrist (necessitating brachial puncture)

Sites / Locations

  • St. Joseph Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cryotherapy

Control

Arm Description

Cryotherapy: 12 ounces of crushed ice place in a plastic bag applied to the radial artery puncture area for 3 minutes

Cryotherapy is not applied to the radial artery puncture area

Outcomes

Primary Outcome Measures

pain
Pain is measured with a 100 mm visual analog scale

Secondary Outcome Measures

Full Information

First Posted
February 14, 2014
Last Updated
February 17, 2014
Sponsor
St. Joseph Hospital, New Hampshire
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1. Study Identification

Unique Protocol Identification Number
NCT02065115
Brief Title
Study of Ice Application to Reduce Pain From Arterial Punctures
Official Title
Cryoanalgesia (Ice Pack) to Reduce the Pain Associated With Arterial Blood Gas Puncture
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph Hospital, New Hampshire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study seeks to determine if cryoanalgesia in the form of ice application could be an effective analgesic when applied before arterial puncture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vessel Puncture Site Pain
Keywords
ice, cryotherapy, puncture, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
Cryotherapy: 12 ounces of crushed ice place in a plastic bag applied to the radial artery puncture area for 3 minutes
Arm Title
Control
Arm Type
No Intervention
Arm Description
Cryotherapy is not applied to the radial artery puncture area
Intervention Type
Other
Intervention Name(s)
Cryotherapy (ice pack)
Primary Outcome Measure Information:
Title
pain
Description
Pain is measured with a 100 mm visual analog scale
Time Frame
1-5 minutes after arterial puncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: subjects ≥ 18 years old referred to the pulmonary function laboratory with a physician order for an arterial blood gas test were sought to complete the study Exclusion Criteria: cold, bluish hands and fingers diagnosis of Raynaud's syndrome or scleroderma/CREST syndrome history or signs of dementia, confusion, or cognitive impairment blindness patients not fluent in the English language non-palpable radial pulse in the wrist (necessitating brachial puncture)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey m Haynes, RRT RPFT
Organizational Affiliation
St. Joseph Hospital, Nashua New Hampshire
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Hospital
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8989058
Citation
Giner J, Casan P, Belda J, Gonzalez M, Miralda RM, Sanchis J. Pain during arterial puncture. Chest. 1996 Dec;110(6):1443-5. doi: 10.1378/chest.110.6.1443.
Results Reference
background
PubMed Identifier
25516991
Citation
Haynes JM. Randomized controlled trial of cryoanalgesia (ice bag) to reduce pain associated with arterial puncture. Respir Care. 2015 Jan;60(1):1-5. doi: 10.4187/respcare.03312. Epub 2014 Dec 16.
Results Reference
derived

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Study of Ice Application to Reduce Pain From Arterial Punctures

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