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

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00130650
First received: August 15, 2005
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Pain
Device: Pain Ease
Phase 4

Study Type: Interventional
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
Official Title: Efficacy of Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • pain score [ Time Frame: at injection (< 1 minute) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anxiety score [ Time Frame: at injectiong (< 1 minute) ] [ Designated as safety issue: No ]
  • satisfaction (nurse, parent) [ Time Frame: <10 minutes post-injection ] [ Designated as safety issue: No ]
  • IV insertion time [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • ease of IV insertion [ Time Frame: immediate ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130650

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: William M Splinter, BSc, MD Children's Hospital of Eastern Ontario
  More Information

No publications provided by Children's Hospital of Eastern Ontario

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Splinter, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00130650     History of Changes
Other Study ID Numbers: 05/31E
Study First Received: August 15, 2005
Last Updated: January 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by Children's Hospital of Eastern Ontario:
IV
cannulation
Injections, Intravenous

ClinicalTrials.gov processed this record on August 20, 2014