Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-28 @ 7:31 AM
Study NCT ID:
NCT03974633
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Three Non-invasive Analgesic Techniques in Pain Prevention During Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-19', 'size': 393782, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-19T15:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes were studied by an investigator that did not participate in the practical part of the trial.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All subjects received four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead, 2cm above the eyebrows, with a 29G needle, after applying each one of the 4 non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain referred per each zone injected: VAS', 'timeFrame': '1 hour max', 'description': 'Pain measured through a Visual Analogic Scale with values from 0 to 10; being 0 complete absence of pain, and 10 the worst pain ever experienced.'}], 'secondaryOutcomes': [{'measure': 'Discomfort associated to non-invasive analgesic techniques', 'timeFrame': '1 hour max', 'description': 'Discomfort associated to non-invasive analgesic techniques. Direct question in the survey in which answer options were each one of the non-invasive analgesic techniques (Cold, VIbration, Anesthetic cream)'}, {'measure': 'Preference of non-invasive analgesic technique', 'timeFrame': '1 hour max', 'description': 'Preference of non-invasive analgesic technique. Direct question in the survey in which possible answer options were each one of the non-invasive analgesic techniques (Cold, VIbration, Anesthetic cream)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analgesia', 'Cryoanalgesia', 'Vibration analgesia', 'Local anesthetic'], 'conditions': ['Injection Pain Prevention']}, 'referencesModule': {'availIpds': [{'url': 'https://docs.google.com/spreadsheets/d/1dEjSUmhIkqAOvh30WaJ0svs6jrdEGDyU5FXHeBuTOF8/edit?usp=sharing', 'type': 'Individual Participant Data Set'}], 'references': [{'pmid': '20883298', 'type': 'BACKGROUND', 'citation': 'Babamiri K, Nassab R. The evidence for reducing the pain of administration of local anesthesia and cosmetic injectables. J Cosmet Dermatol. 2010 Sep;9(3):242-5. doi: 10.1111/j.1473-2165.2010.00503.x.'}, {'pmid': '26957683', 'type': 'BACKGROUND', 'citation': 'Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.'}, {'pmid': '23985640', 'type': 'BACKGROUND', 'citation': 'Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2.'}, {'pmid': '20483194', 'type': 'BACKGROUND', 'citation': 'Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.'}, {'pmid': '8169463', 'type': 'BACKGROUND', 'citation': 'Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.'}, {'pmid': '17413628', 'type': 'BACKGROUND', 'citation': 'Elibol O, Ozkan B, Hekimhan PK, Caglar Y. Efficacy of skin cooling and EMLA cream application for pain relief of periocular botulinum toxin injection. Ophthalmic Plast Reconstr Surg. 2007 Mar-Apr;23(2):130-3. doi: 10.1097/IOP.0b013e318030459c.'}, {'pmid': '1350007', 'type': 'BACKGROUND', 'citation': 'Simons FE, Gillespie CA, Simons KJ. Local anaesthetic creams and intradermal skin tests. Lancet. 1992 May 30;339(8805):1351-2. doi: 10.1016/0140-6736(92)91994-j. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Injections are associated to a certain level of pain which tolerance can vary between individuals. As regards non-invasive pain control techniques in subcutaneous injections, scarce literature exists with adequate levels of evidence and design quality to support any specific analgesic method.\n\nIn this study, the investigators evaluated the effectivity of three non-invasive analgesic techniques (cold, anesthetic cream and vibration) when performing subcutaneous forehead injections, in a series of 100 healthy volunteers.', 'detailedDescription': 'This study is a randomized, controlled, simple-blind clinical trial, and it has been approved by the Ethics Committee of the Medical Research Institute Hospital La Fe. The study included 100 healthy volunteered, and it was performed in the University and Polytechnic Hospital La Fe, Valencia.\n\nThe procedures of the study consisted in the sequential performance of four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead of each subject, 2cm above the eyebrows, with a 29G needle, after applying any of the non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization. Injections always started from the right side of the forehead to the left. The non-invasive analgesic methods utilized were:\n\n* Control zone: None\n* Vibration: Application of the vibrating device on the skin below the injection site, before and during injection.\n* Cold: Application of a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds prior to performing the injection.\n* Anesthetic cream: Application of a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes, before injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every subject who did not meet any of the exclusion criteria, and signed the informed consent, was included in the study\n\nExclusion Criteria:\n\n* Subjects younger than 18\n* Subjects that suffered from any local or systemic sensitivity alteration\n* Subjects that suffered from any cognitive deficit\n* Individuals allergic to any of the components of the anesthetic ointment EMLA (eutectic mixture of lidocaine 2,5% and prilocaine 2,5%).'}, 'identificationModule': {'nctId': 'NCT03974633', 'briefTitle': 'Evaluation of Three Non-invasive Analgesic Techniques in Pain Prevention During Injections', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigacion Sanitaria La Fe'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating Three Non-invasive Analgesic Techniques in Pain Prevention During Injections', 'orgStudyIdInfo': {'id': '2018/0547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, without administering any type of non-invasive analgesic', 'interventionNames': ['Combination Product: Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Vibration', 'description': 'A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, while applicating a vibrating device on the skin below the injection site, before and during injection.', 'interventionNames': ['Combination Product: Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Cold', 'description': 'A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds', 'interventionNames': ['Combination Product: Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Anesthetic cream', 'description': 'subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes', 'interventionNames': ['Combination Product: Injection']}], 'interventions': [{'name': 'Injection', 'type': 'COMBINATION_PRODUCT', 'description': 'All information is included in the Arm/group descriptions', 'armGroupLabels': ['Anesthetic cream', 'Cold', 'Control', 'Vibration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'University and Polytechnic Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Enrique Salmeron-Gonzalez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University and Polytechnic Hospital La Fe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enrique Salmeron', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enrique Salmeron', 'investigatorAffiliation': 'Instituto de Investigacion Sanitaria La Fe'}}}}