Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00130650
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2005-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-24', 'studyFirstSubmitDate': '2005-08-15', 'studyFirstSubmitQcDate': '2005-08-15', 'lastUpdatePostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'at injection (< 1 minute)'}], 'secondaryOutcomes': [{'measure': 'anxiety score', 'timeFrame': 'at injectiong (< 1 minute)'}, {'measure': 'satisfaction (nurse, parent)', 'timeFrame': '<10 minutes post-injection'}, {'measure': 'IV insertion time', 'timeFrame': 'immediate'}, {'measure': 'ease of IV insertion', 'timeFrame': 'immediate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IV', 'cannulation', 'Injections, Intravenous'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '18591524', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nWe, 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.\n\nMedications 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-12 years old\n* Require an IV inserted in less than 30 minutes\n\nExclusion Criteria:\n\n* Allergy to vapocoolant sprays\n* Vascular impairment\n* Diabetes mellitus\n* Developmental delay/inability to understand pain scale\n* Received analgesia in last 24 hours\n* Triaged as resuscitation'}, 'identificationModule': {'nctId': 'NCT00130650', 'briefTitle': 'Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Eastern Ontario"}, 'officialTitle': 'Efficacy of Pain Ease Spray in Reducing Needle Pain Associated With Intravenous Insertion in Children', 'orgStudyIdInfo': {'id': '05/31E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pain Ease', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'William M Splinter, BSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Eastern Ontario"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Eastern Ontario", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'William Splinter', 'oldOrganization': "Children's Hospital of Eastern Ontario"}}}}