Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-27 @ 5:05 AM
Study NCT ID:
NCT02408302
Status:
UNKNOWN
Last Update Posted:
2015-04-09
First Post:
2015-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time until sedation is achieved', 'timeFrame': '1 hour'}, {'measure': 'duration of sedation', 'timeFrame': '4 hour', 'description': 'time from achieving sedation until reaching full consciousness'}, {'measure': 'convenience of administration', 'timeFrame': '15 minutes', 'description': 'described by the parent and the physician by a numerical rating scale (NRS) questionaire'}, {'measure': 'efficacy of the sedation', 'timeFrame': '4 hours', 'description': 'described by the parent, nurse and physician by a NRS questionaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dormicum', 'Conscious Sedation', 'Children']}, 'referencesModule': {'references': [{'pmid': '10738053', 'type': 'BACKGROUND', 'citation': 'Krauss B, Green SM. Sedation and analgesia for procedures in children. N Engl J Med. 2000 Mar 30;342(13):938-45. doi: 10.1056/NEJM200003303421306. No abstract available.'}, {'pmid': '16517277', 'type': 'BACKGROUND', 'citation': 'Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. doi: 10.1016/S0140-6736(06)68230-5.'}, {'pmid': '17142550', 'type': 'BACKGROUND', 'citation': 'American Academy of Pediatrics; American Academy of Pediatric Dentistry; Cote CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Pediatrics. 2006 Dec;118(6):2587-602. doi: 10.1542/peds.2006-2780.'}, {'pmid': '1235980', 'type': 'BACKGROUND', 'citation': 'Procacci P, Francini F, Zoppi M, Maresca M. Cutaneous pain threshold changes after sympathetic block in reflex dystrophies. Pain. 1975 Jun;1(2):167-175. doi: 10.1016/0304-3959(75)90100-1.'}, {'pmid': '11964611', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002 Apr;96(4):1004-17. doi: 10.1097/00000542-200204000-00031. No abstract available.'}, {'pmid': '15671976', 'type': 'BACKGROUND', 'citation': 'Godwin SA, Caro DA, Wolf SJ, Jagoda AS, Charles R, Marett BE, Moore J; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2005 Feb;45(2):177-96. doi: 10.1016/j.annemergmed.2004.11.002. No abstract available.'}, {'pmid': '23435653', 'type': 'BACKGROUND', 'citation': 'Shavit I, Feraru L, Miron D, Weiser G. Midazolam for urethral catheterisation in female infants with suspected urinary tract infection: a case-control study. Emerg Med J. 2014 Apr;31(4):278-80. doi: 10.1136/emermed-2012-202088. Epub 2013 Feb 22.'}, {'pmid': '12712062', 'type': 'BACKGROUND', 'citation': 'McErlean M, Bartfield JM, Karunakar TA, Whitman MC, Turley DM. Midazolam syrup as a premedication to reduce the discomfort associated with pediatric intravenous catheter insertion. J Pediatr. 2003 Apr;142(4):429-30. doi: 10.1067/mpd.2003.62.'}, {'pmid': '18496113', 'type': 'BACKGROUND', 'citation': 'Lane RD, Schunk JE. Atomized intranasal midazolam use for minor procedures in the pediatric emergency department. Pediatr Emerg Care. 2008 May;24(5):300-3. doi: 10.1097/PEC.0b013e31816ecb6f.'}, {'pmid': '16440479', 'type': 'BACKGROUND', 'citation': 'Wiznitzer M. Buccal midazolam is effective for acute treatment of seizures. J Pediatr. 2006 Jan;148(1):143. doi: 10.1016/j.jpeds.2005.12.008. No abstract available.'}, {'pmid': '16023491', 'type': 'BACKGROUND', 'citation': 'Wiznitzer M. Buccal midazolam for seizures. Lancet. 2005 Jul 16-22;366(9481):182-3. doi: 10.1016/S0140-6736(05)66884-5. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal.\n\nA third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '5 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 5 months to 6 years.\n* need to undergo a minimal invasive procedure that requires light sedation.\n* ASA (American Society of Anesthesiologists) I-II\n* parent that can read, understand and sign an informed consent form\n\nExclusion Criteria:\n\n* patients with life threatening conditions.\n* patients with respiratory or cardiac chronic illnesses or ASA other than I-II.\n* patients with traumatic injury for the nose or the oral cavity.\n* patients that would not or cannot take the drug in the route picked in a randomized way.'}, 'identificationModule': {'nctId': 'NCT02408302', 'briefTitle': 'Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study', 'orgStudyIdInfo': {'id': 'CMC-13-0075-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oral midazolam', 'description': 'oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.', 'interventionNames': ['Drug: Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intranasal midazolam', 'description': 'intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure', 'interventionNames': ['Drug: Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'buccal midazolam', 'description': 'buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Dormicum'], 'description': 'comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.', 'armGroupLabels': ['buccal midazolam', 'intranasal midazolam', 'oral midazolam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'contacts': [{'name': 'Muriel Konopnicki, MD', 'role': 'CONTACT', 'email': 'MurielKo2@clalit.org.il', 'phone': '972-4-8250240'}, {'name': 'Muriel Konopnicki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Muriel Konopnicki', 'role': 'CONTACT', 'email': 'MurielKo2@clalit.org.il', 'phone': '972-4-8250240'}], 'overallOfficials': [{'name': 'Muriel Konopnicki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmal Medical Center, Haifa, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pediatric emergency room', 'investigatorFullName': 'Muriel Konopnicki', 'investigatorAffiliation': 'Carmel Medical Center'}}}}