Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04473820
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2020-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Lidocaine-Prilocaine Combination and Vapocoolant for IV Cannulation Pain in the ED
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cannulation pain: numerical rating score (NRS)', 'timeFrame': 'immediately after the procedure.', 'description': 'The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.'}], 'secondaryOutcomes': [{'measure': 'Application pain: numerical rating score (NRS)', 'timeFrame': 'immediately after the procedure.', 'description': 'The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.'}, {'measure': 'Catheterization attempts', 'timeFrame': 'immediately after the procedure.', 'description': 'Number of times the direction of IV catheter is changed before the successful cannulation. Exit from the skin is also considered an attempt.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '40118519', 'type': 'DERIVED', 'citation': 'Akhgar A, Mazidabadi Farahani A, Akbari H, Sedaghat M, Jalili M, Mirfazaelian H. Comparison of the effects of vapocoolant spray and topical anaesthetic cream (lidocaine-prilocaine) on pain of intravenous cannulation: a randomised controlled trial. Emerg Med J. 2025 May 22;42(6):373-377. doi: 10.1136/emermed-2024-214479.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.', 'detailedDescription': 'Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia through crayoanesthetic mechanisms. Although there are some contraindications and adverse effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low acute patients who are waiting for the admission to the ED and require IV cannulation\n\nExclusion Criteria:\n\n* Altered mental status\n* Uncooperative patients\n* Unable to communicate\n* Known history of hypersensitivity reaction to cold or amid analgesics\n* Analgesic usage in previous 6 hours\n* No consent\n* Emergent condition\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT04473820', 'briefTitle': 'Comparison of Lidocaine-Prilocaine Combination and Vapocoolant for IV Cannulation Pain in the ED', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Comparison of The Efficacy of Lidocaine-Prilocaine Combination and Vapocoolant Spray to Reduce Pain of IV Cannulation in The Emergency Department: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '9111215292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vapocoolant spray', 'description': 'Patients in this arm will receive vapocoolant spray before IV cannulation.', 'interventionNames': ['Drug: Vapocoolant spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine-Prilocaine cream', 'description': 'Patients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation.', 'interventionNames': ['Drug: Lidocaine-Prilocaine cream']}], 'interventions': [{'name': 'Vapocoolant spray', 'type': 'DRUG', 'description': 'The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.', 'armGroupLabels': ['Vapocoolant spray']}, {'name': 'Lidocaine-Prilocaine cream', 'type': 'DRUG', 'description': 'A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.', 'armGroupLabels': ['Lidocaine-Prilocaine cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'IKCH', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Emergency Medicine', 'investigatorFullName': 'Hadi Mirfazaelian', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}