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Completed

NCT Number: NCT00130650

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Ease

Device

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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Aug 16, 2005
Registry last updated
Jan 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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