Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT02300194
Status:
WITHDRAWN
Last Update Posted:
2020-04-22
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn by investigators', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Reduction', 'timeFrame': '4 hours', 'description': 'Proportion of patients with a reduction in pain of least 2 point according to FLACC scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain management'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '19030643', 'type': 'BACKGROUND', 'citation': 'Garcia Roig C, Caprotta G, de Castro MF, Germ RM, Lagomarsino E. [Analgesia and sedation in pediatric procedures Part 1: general aspects, sedation scales and pain assessment]. Arch Argent Pediatr. 2008 Oct;106(5):429-34. doi: 10.1590/S0325-00752008000500010. No abstract available. Spanish.'}, {'pmid': '16969231', 'type': 'BACKGROUND', 'citation': 'Shavit I, Keidan I, Augarten A. The practice of pediatric procedural sedation and analgesia in the emergency department. Eur J Emerg Med. 2006 Oct;13(5):270-5. doi: 10.1097/00063110-200610000-00005.'}, {'pmid': '22658469', 'type': 'BACKGROUND', 'citation': 'Nielsen BN, Aagaard G, Henneberg SW, Schmiegelow K, Hansen SH, Romsing J. Topical morphine for oral mucositis in children: dose finding and absorption. J Pain Symptom Manage. 2012 Jul;44(1):117-23. doi: 10.1016/j.jpainsymman.2011.06.029. Epub 2012 Jun 1.'}, {'pmid': '22964846', 'type': 'BACKGROUND', 'citation': 'Heilmann S, Kuchler S, Schafer-Korting M. Morphine metabolism in human skin microsomes. Skin Pharmacol Physiol. 2012;25(6):319-22. doi: 10.1159/000342067. Epub 2012 Sep 8.'}, {'pmid': '15120772', 'type': 'BACKGROUND', 'citation': 'Ribeiro MD, Joel SP, Zeppetella G. The bioavailability of morphine applied topically to cutaneous ulcers. J Pain Symptom Manage. 2004 May;27(5):434-9. doi: 10.1016/j.jpainsymman.2003.09.011.'}, {'pmid': '15210505', 'type': 'BACKGROUND', 'citation': 'Watterson G, Howard R, Goldman A. Peripheral opioids in inflammatory pain. Arch Dis Child. 2004 Jul;89(7):679-81. doi: 10.1136/adc.2003.032003.'}, {'pmid': '18613934', 'type': 'BACKGROUND', 'citation': 'Nilsson S, Finnstrom B, Kokinsky E. The FLACC behavioral scale for procedural pain assessment in children aged 5-16 years. Paediatr Anaesth. 2008 Aug;18(8):767-74. doi: 10.1111/j.1460-9592.2008.02655.x.'}], 'seeAlsoLinks': [{'url': 'https://apps.who.int/iris/handle/10665/77943', 'label': 'World Health Organization 2012'}]}, 'descriptionModule': {'briefSummary': 'Introduction:\n\nOpioids, such as morphine, act at receptors in the central nervous system, but many studies have suggested direct action peripherally on opioid receptors in sensory neurons terminals, melanocytes, keratinocytes and fibroblasts. These receptors are stimulated when occurs inflammatory processes.\n\nHypothesis:\n\nTreatment with topical morphine 0.1% applied 30 minutes before an invasive procedure, decreases pain in children.\n\nMethod:\n\nA randomised double-blind parallel study to evaluate the effect of topical application of a 0.1% morphine gel in patients undergo a procedure. 22 patients in each group will be included. Randomly assigned to either the morphine gel or a placebo hydrogel, it will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with "Face, Legs, Activity, Cry, Consolability scale" (FLACC scale).', 'detailedDescription': 'The use of an opioid such as morphine topical gel 30 minutes before a procedure would be effective in reducing pain in children. It has proven effective analgesic with minimal adverse effects, especially in children older than 6 months, and even its use is authorized in young children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized children aged 1 month to 10 years, who needs a medical procedure over previously injured skin, associated with moderate-severe pain.\n\nExclusion Criteria:\n\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT02300194', 'briefTitle': 'Randomized, Double-blind, Placebo, Controlled Cross Over Design Topical Morphine for Analgesia in Pediatric Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General de Niños Pedro de Elizalde'}, 'officialTitle': 'Topical Morphine for Analgesia in Pediatric Procedures. Clinical Trial Randomized, Double-blind, Placebo.', 'orgStudyIdInfo': {'id': 'HGNPE-157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topic Morphine', 'description': 'Use of topic morphine for treatment of procedure associated pain', 'interventionNames': ['Drug: Topic Morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Use of topic hydrogel (placebo) for treatment of procedure associated pain', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Topic Morphine', 'type': 'DRUG', 'otherNames': ['Morphine gel'], 'description': 'Topical application of a 0.1% morphine gel in patients undergo a procedure. It will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with FLACC scale.', 'armGroupLabels': ['Topic Morphine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo hidrogel'], 'description': 'Topical application of a placebo hydrogel in patients undergo a procedure. It will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with FLACC scale.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1270AAN', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital General de Niños Pedro de Elizalde', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'María L Yazde-Puleio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General de Niños Pedro de Elizalde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General de Niños Pedro de Elizalde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}