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

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ClinicalTrials.gov Identifier: NCT00130650
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : January 25, 2008
Information provided by:
Children's Hospital of Eastern Ontario

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Device: Pain Ease Phase 4

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children
Study Start Date : May 2006
Primary Completion Date : September 2006
Study Completion Date : September 2006

Primary Outcome Measures :
  1. pain score [ Time Frame: at injection (< 1 minute) ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130650

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

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
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Methyl salicylate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action