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CompletedNCT00130650Updated Jan 25, 2008

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

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

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • IV
  • cannulation
  • Injections, Intravenous
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 6-12 years old
  • Require an IV inserted in less than 30 minutes

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Interventions

  • DevicePain Ease
06

What researchers measure

Primary outcomes

  1. pain score

    Time frame: at injection (< 1 minute)

Secondary outcomes

  1. anxiety score

    Time frame: at injectiong (< 1 minute)

  2. satisfaction (nurse, parent)

    Time frame: <10 minutes post-injection

  3. IV insertion time

    Time frame: immediate

  4. ease of IV insertion

    Time frame: immediate

07

Study locations

1 site
  • Children's Hospital of Eastern Ontario
    Ottawa, Ontario K1H 8L1, Canada
08

References and documents

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. PubMed 18591524 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00130650
Lead sponsor
Children's Hospital of Eastern Ontario
First posted
Aug 16, 2005
Start date
May 2006
Primary completion
Sep 2006
Completion
Sep 2006
Last update
Jan 25, 2008

Study contacts

William M Splinter, BSc, MD
principal investigator · Children's Hospital of Eastern Ontario

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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