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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Pain Ease

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Investigators: Principal Investigator: William M Splinter, BSc, MD, Children's Hospital of Eastern Ontario

Publications and helpful links

General Publications

• Farion KJ, Splinter KL, Newhook K, Gaboury I, Splinter WM. The effect of vapocoolant spray on pain due to intravenous cannulation in children: a randomized controlled trial. CMAJ. 2008 Jul 1;179(1):31-6. doi: 10.1503/cmaj.070874.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (ACTUAL): September 1, 2006
• Study Completion (ACTUAL): September 1, 2006

Study Registration Dates

• First Submitted: August 15, 2005
• First Submitted That Met QC Criteria: August 15, 2005
• First Posted (ESTIMATE): August 16, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): January 25, 2008
• Last Update Submitted That Met QC Criteria: January 24, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: cannulation; Injections, Intravenous; IV
• Other Study ID Numbers: 05/31E