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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130650
• Other study ID #: 05/31E
• Status: Completed
• Phase: Phase 4
• First received: August 15, 2005
• Last updated: January 24, 2008
• Start date: May 2006
• Est. completion date: September 2006

Study information

• Verified date: January 2008
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Pain Ease

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score		at injection (< 1 minute)	No
Secondary	anxiety score		at injectiong (< 1 minute)	No
Secondary	satisfaction (nurse, parent)		<10 minutes post-injection	No
Secondary	IV insertion time		immediate	No
Secondary	ease of IV insertion		immediate	No