Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children|
- pain score [ Time Frame: at injection (< 1 minute) ] [ Designated as safety issue: No ]
- anxiety score [ Time Frame: at injectiong (< 1 minute) ] [ Designated as safety issue: No ]
- satisfaction (nurse, parent) [ Time Frame: <10 minutes post-injection ] [ Designated as safety issue: No ]
- IV insertion time [ Time Frame: immediate ] [ Designated as safety issue: No ]
- ease of IV insertion [ Time Frame: immediate ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130650
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||William M Splinter, BSc, MD||Children's Hospital of Eastern Ontario|