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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Device: Pain Ease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-12 years old Require an IV inserted in less than 30 minutes Exclusion Criteria: Allergy to vapocoolant sprays Vascular impairment Diabetes mellitus Developmental delay/inability to understand pain scale Received analgesia in last 24 hours Triaged as resuscitation

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pain Ease|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score |  | at injection (< 1 minute) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety score |  | at injectiong (< 1 minute) | 
| satisfaction (nurse, parent) |  | <10 minutes post-injection | 
| IV insertion time |  | immediate | 
| ease of IV insertion |  | immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV, cannulation, Injections, Intravenous