- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065115
Study of Ice Application to Reduce Pain From Arterial Punctures
November 26, 2024 updated by: St. Joseph Hospital, New Hampshire
Cryoanalgesia (Ice Pack) to Reduce the Pain Associated With Arterial Blood Gas Puncture
This study seeks to determine if cryoanalgesia in the form of ice application could be an effective analgesic when applied before arterial puncture.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Nashua, New Hampshire, United States, 03060
- St. Joseph Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cryotherapy
Cryotherapy: 12 ounces of crushed ice place in a plastic bag applied to the radial artery puncture area for 3 minutes
|
|
|
No Intervention: Control
Cryotherapy is not applied to the radial artery puncture area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain related to arterial puncture
Time Frame: 1-5 minutes after arterial puncture
|
Pain is measured with a 100 mm visual analog scale
|
1-5 minutes after arterial puncture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey m Haynes, RRT RPFT, St. Joseph Hospital, Nashua New Hampshire
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
February 14, 2014
First Submitted That Met QC Criteria
February 14, 2014
First Posted (Estimated)
February 17, 2014
Study Record Updates
Last Update Posted (Actual)
November 29, 2024
Last Update Submitted That Met QC Criteria
November 26, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJH IRB 2012-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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