Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130650
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2005-08-15
Brief Title:
Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
Efficacy of Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the use of a new vapocoolant spray Pain Ease to reduce intravenous IV insertion pain in school-aged children receiving treatment in the Emergency Department
Detailed Description:
Inserting a needle into a childs vein is a distressing experience for children Reducing the pain of injection and avoiding the childs discomfort remains an important aim for both parents and health care workers Withdrawing blood and intravenous insertion IV in children is also time consuming especially when the child is uncooperative and stressed
We the researchers at Childrens Hospital of Eastern Ontario have been searching for an effective rapid and inexpensive method to alleviate the distress associated with venipuncture and IV insertion
Medications by mouth such as anti-anxiety drugs are helpful but usually do not significantly reduce the pain The most commonly used anti-anxiety drug at our institution is midazolam but unfortunately onset of action takes 20-30 minutes There are various forms of topical creams that can numb the skin EMLA a mixture of two local anesthetics Lidocaine 25 and Prilocaine 25 is applied as a topical cream and is covered with an occlusive dressing It requires at least 1 hour to be effective It is not only time consuming but expensive 130 per application Ametop Tetracaine PH Eur4ww is another effective topical cream which works in 30 minutes but it is more expensive than EMLA 300 per application Vapocoolant sprays applied for 10 seconds immediately before injection have been shown to be faster less expensive and as effective as EMLA in reducing pain at the site of injection during immunization
The current investigation will evaluate the quality efficacy and costs associated with the use of a new vapocoolant spray Pain Ease in reducing pain associated with IV insertion for school age children
We the researchers at Childrens Hospital of Eastern Ontario have been searching for an effective rapid and inexpensive method to alleviate the distress associated with venipuncture and IV insertion
Medications by mouth such as anti-anxiety drugs are helpful but usually do not significantly reduce the pain The most commonly used anti-anxiety drug at our institution is midazolam but unfortunately onset of action takes 20-30 minutes There are various forms of topical creams that can numb the skin EMLA a mixture of two local anesthetics Lidocaine 25 and Prilocaine 25 is applied as a topical cream and is covered with an occlusive dressing It requires at least 1 hour to be effective It is not only time consuming but expensive 130 per application Ametop Tetracaine PH Eur4ww is another effective topical cream which works in 30 minutes but it is more expensive than EMLA 300 per application Vapocoolant sprays applied for 10 seconds immediately before injection have been shown to be faster less expensive and as effective as EMLA in reducing pain at the site of injection during immunization
The current investigation will evaluate the quality efficacy and costs associated with the use of a new vapocoolant spray Pain Ease in reducing pain associated with IV insertion for school age children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None