Clinical Trials Directory

Trials / Completed

CompletedNCT00130650

Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children

Efficacy of Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Children's Hospital of Eastern Ontario · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Not accepted

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 child's vein is a distressing experience for children. Reducing the pain of injection and avoiding the child's 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 Children's 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 2.5% and Prilocaine 2.5%), 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 (\~$1.30 per application). Ametop (Tetracaine PH. Eur.4%w/w) is another effective topical cream, which works in 30 minutes, but it is more expensive than EMLA (\~$3.00 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.

Conditions

Interventions

TypeNameDescription
DEVICEPain Ease

Timeline

Start date
2006-05-01
Primary completion
2006-09-01
Completion
2006-09-01
First posted
2005-08-16
Last updated
2008-01-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00130650. Inclusion in this directory is not an endorsement.