A Phase 4 interventional study of Pain Ease in Pain, sponsored by Children's Hospital of Eastern Ontario. Completed at 1 site in Canada. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2008-01-25.
Sponsored by Children's Hospital of Eastern Ontario · Phase 4, Interventional, and Treatment
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.
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.
Children's Hospital of Eastern Ontario is the lead sponsor of 83 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
pain score
Time frame: at injection (< 1 minute)
anxiety score
Time frame: at injectiong (< 1 minute)
satisfaction (nurse, parent)
Time frame: <10 minutes post-injection
IV insertion time
Time frame: immediate
ease of IV insertion
Time frame: immediate
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Eastern Ontario