Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-19 @ 5:30 PM
Study NCT ID:
NCT02250703
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2014-09-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Dexmedetomidine Premedication in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], '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'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msathyamoorthy@umc.edu', 'phone': '6018157066', 'title': 'Madhankumar Sathyamoorthy. PI', 'organization': 'University of Mississippi Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'All the consecutive patients were screened for eligibility. Patients were not selected on the basis of need for premedication.'}}, 'adverseEventsModule': {'timeFrame': 'After premedication, patients will be continuously monitored including HR, BP, RR and SPO2 and documented every 15 min', 'eventGroups': [{'id': 'EG000', 'title': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication\n\nMidazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).\n\nDexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'University of Michigan Sedation Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication\n\nMidazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).\n\nDexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg'}], 'classes': [{'title': 'Satisfactory sedation on separation from parents', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Unsatisfactory sedation on separation from parents', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Satisfactory sedation on transfer to OR table', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Unsatisfactory sedation on transfer to OR table', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)', 'groupDescription': 'A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0:Just before the patient will be brought to the operating room', 'description': 'Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)\n\nUniversity of Michigan Sedation Scale:\n\n0 -Awake/Alert\n\n1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.\n\n2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.\n\n3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.\n\n4 - Unarousable\n\nModerately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptance of Mask Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication\n\nMidazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).\n\nDexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg'}], 'classes': [{'categories': [{'title': 'Satisfactory mask induction', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'unsatisfactory mask induction', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0: At the time when anesthesia is induced', 'description': 'on a scale of 1 to 4\n\n1. excellent( cooperative)\n2. good( slight fear, easily calmed)\n3. fair ( moderate fear, not calmed with reassurance)\n4. Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Wake up Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication\n\nMidazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).\n\nDexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg'}], 'classes': [{'categories': [{'title': 'satisfactory wake up behavior', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'unsatisfactory wake up behavior', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0: At the end of surgery when the patient recovers from anesthesia', 'description': 'assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4\n\n1. calm\n2. not calm but easily calmed\n3. moderately agitated or restless\n4. combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Amnesia to Mask Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication\n\nMidazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg'}, {'id': 'OG001', 'title': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).\n\nDexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg'}], 'classes': [{'categories': [{'title': 'memory of mask induction-yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'memory of mask induction-no', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0: at the time of discharge of the patient from the recovery room', 'description': 'Yes or No (if the patient remembers mask induction)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication\n\nMidazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg'}, {'id': 'FG001', 'title': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).\n\nDexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication\n\nMidazolam: oral midazolam 0.5mg/kg upto maximum dose of 15mg'}, {'id': 'BG001', 'title': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).\n\nDexmedetomidine: intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.62', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '3.37', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2014-09-05', 'resultsFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2014-09-25', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-29', 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'University of Michigan Sedation Scale', 'timeFrame': 'Day 0:Just before the patient will be brought to the operating room', 'description': 'Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)\n\nUniversity of Michigan Sedation Scale:\n\n0 -Awake/Alert\n\n1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.\n\n2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.\n\n3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.\n\n4 - Unarousable\n\nModerately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory'}], 'secondaryOutcomes': [{'measure': 'Acceptance of Mask Induction', 'timeFrame': 'Day 0: At the time when anesthesia is induced', 'description': 'on a scale of 1 to 4\n\n1. excellent( cooperative)\n2. good( slight fear, easily calmed)\n3. fair ( moderate fear, not calmed with reassurance)\n4. Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory'}, {'measure': 'Wake up Behavior', 'timeFrame': 'Day 0: At the end of surgery when the patient recovers from anesthesia', 'description': 'assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4\n\n1. calm\n2. not calm but easily calmed\n3. moderately agitated or restless\n4. combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory'}, {'measure': 'Presence of Amnesia to Mask Induction', 'timeFrame': 'Day 0: at the time of discharge of the patient from the recovery room', 'description': 'Yes or No (if the patient remembers mask induction)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premedication'], 'conditions': ['Preoperative Sedation']}, 'referencesModule': {'references': [{'pmid': '9024042', 'type': 'BACKGROUND', 'citation': 'Kain ZN, Mayes LC, Bell C, Weisman S, Hofstadter MB, Rimar S. Premedication in the United States: a status report. Anesth Analg. 1997 Feb;84(2):427-32. doi: 10.1097/00000539-199702000-00035.'}, {'pmid': '15787915', 'type': 'BACKGROUND', 'citation': 'Lonnqvist PA, Habre W. Midazolam as premedication: is the emperor naked or just half-dressed? Paediatr Anaesth. 2005 Apr;15(4):263-5. doi: 10.1111/j.1460-9592.2005.01600.x. No abstract available.'}, {'pmid': '14578832', 'type': 'BACKGROUND', 'citation': 'Kanegaye JT, Favela JL, Acosta M, Bank DE. High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003 Oct;19(5):329-36. doi: 10.1097/01.pec.0000092578.40174.85.'}, {'pmid': '9549736', 'type': 'BACKGROUND', 'citation': 'McGraw T, Kendrick A. Oral midazolam premedication and postoperative behaviour in children. Paediatr Anaesth. 1998;8(2):117-21. doi: 10.1046/j.1460-9592.1998.00724.x.'}, {'pmid': '15105196', 'type': 'RESULT', 'citation': 'Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004 May;98(5):1252-9, table of contents. doi: 10.1213/01.ane.0000111183.38618.d8.'}, {'pmid': '18499600', 'type': 'RESULT', 'citation': 'Yuen VM, Hui TW, Irwin MG, Yuen MK. A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial. Anesth Analg. 2008 Jun;106(6):1715-21. doi: 10.1213/ane.0b013e31816c8929.'}, {'pmid': '22268591', 'type': 'RESULT', 'citation': 'Akin A, Bayram A, Esmaoglu A, Tosun Z, Aksu R, Altuntas R, Boyaci A. Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthesia. Paediatr Anaesth. 2012 Sep;22(9):871-6. doi: 10.1111/j.1460-9592.2012.03802.x. Epub 2012 Jan 23.'}, {'pmid': '24237879', 'type': 'RESULT', 'citation': 'Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.'}, {'pmid': '22950484', 'type': 'RESULT', 'citation': 'Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.'}, {'pmid': '31318038', 'type': 'DERIVED', 'citation': 'Sathyamoorthy M, Hamilton TB, Wilson G, Talluri R, Fawad L, Adamiak B, Wallace C, Borissova I, Heard C. Pre-medication before dental procedures: A randomized controlled study comparing intranasal dexmedetomidine with oral midazolam. Acta Anaesthesiol Scand. 2019 Oct;63(9):1162-1168. doi: 10.1111/aas.13425. Epub 2019 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'BACKGROUND INFORMATION AND RATIONALE\n\nPediatric patients scheduled for dental procedures under general anesthesia can have significant anxiety before the procedure. They are commonly pre medicated to minimize distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose is more widely used for this purpose . However the commonly used maximum dose is up to 15mg. It also has many limitations such as paradoxical reaction, increased incidence of emergence delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been used an effective and safe alternative premedication to oral midazolam in children. At a dose of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as providing analgesia and facilitating smooth emergence from anesthesia.\n\nThe goal of this study is to find out if intranasal dexmedetomidine is a superior alternative as premedication to oral midazolam in children weighing more than 20kg undergoing general anesthesia for dental rehabilitation.', 'detailedDescription': "After Institutional Review Board (IRB) approval and written informed consent from patients' parents or legally authorized representative, 80 children older than 5yrs and weighing more than 20kg, ASA physical status 1 or 2, scheduled for elective dental rehabilitation with general anesthesia will be enrolled in this prospective randomized double blinded study.\n\nExclusion criteria include known allergy or hypersensitivity to midazolam or dexmedetomidine, uncorrected congenital heart disease or history of cardiac arrhythmia, children at risk for airway obstruction (OSA or cranio facial syndrome) and pregnant minors Patients will be randomly assigned to one of two groups M (midazolam) or D (dexmedetomidine) using computer-generated numbers in sealed envelopes.\n\nAll the patients will be brought to their pre-op room and premedicated at least 30 min before induction of anesthesia.\n\nIn M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup.\n\nIn D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R). The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM). Atomized nasal medications offer rapid absorption across mucosal membranes to the blood stream avoiding first-pass metabolism.\n\nParents will be present in the room during premedication. The Anesthesia personnel involved in the care of the patient (MD or CRNA) will prepare and administer all study drugs. All patients will be continuously monitored in the holding area with pulse oximetry and blood pressure monitor. HR, SPO2 and BP will be recorded every 15min after administration of premedication until transfer to the OR. Emergency medications including atropine and epinephrine will be immediately available in the pre-op holding area. Oral midazolam has been used with very little effect on hemodynamic parameters. Although intranasal dexmedetomidine can decrease HR and BP, it has been used at the dose of 2mcg/kg without any adverse hemodynamic effect . Any intervention needed to treat drop in HR (\\<50) and BP (sys BP \\<60) after the drug administration will be recorded.\n\nBehavior of the children at the time of premedication will be documented ( easy or difficult). Any unwanted effects during administration such as spitting or vomiting of oral drug and pain or irritation from nasal administration will be documented.\n\nThe dental resident blinded to study drug administration will do the pre-operative sedation status and acceptance of mask induction.\n\nSedation status will be assessed using University of Michigan sedation scale (UMSS)on separation from parents and at induction after moving to the OR table. Acceptance of mask induction will be documented on a 4-point scale.\n\nStandard ASA monitors will be applied before induction of anesthesia. All patients will undergo mask induction with O2/N2O/Sevo. An intravenous line will be inserted and secured. Both nostrils will be prepped nasal drops and tips of tracheal tubes covered with red rubber to minimize bleeding. Nasal intubation will be performed with direct laryngoscopy and McGill's forceps. Appropriate size cuffed tracheal tubes will be inserted and secured after additional IV medications with propofol 2-3mg/kg and fentanyl 1-2mcg/kg. Anesthesia will be maintained with O2/Sevo, IV morphine 0.05 to 0.1mg/kg and IV toradol 0.5mg/kg (if there is no allergy or contraindication to morphine or toradol) After the completion of procedure, patients will be extubated in the operating room and brought to recovery room and allowed to wake up slowly in the recovery position.\n\nPACU nurses will evaluate Behavior at awakening using four-point wake up score (9,20). Patients will also be asked if they remember mask induction (yes or no) when they are ready for discharge. Incidence of nausea, vomiting, shivering will be documented in PACU. Time spent in phase 1 recovery room will also be recorded ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children older than 5yrs and weighing more than 20kg , who are scheduled for ambulatory dental rehabilitation at Batson operating rooms.\n* ASA classification 1 or 2\n\nExclusion Criteria\n\n* Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and propofol.\n* uncorrected congenital heart disease or history of cardiac arrhythmia,\n* children at risk for airway obstruction (OSA or cranio facial syndrome),\n* pregnant minors'}, 'identificationModule': {'nctId': 'NCT02250703', 'briefTitle': 'Intranasal Dexmedetomidine Premedication in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Comparing Intranasal Dexmedetomidine With Oral Midazolam as Premedication for Older Children Undergoing General Anesthesia for Dental Rehabilitation', 'orgStudyIdInfo': {'id': '2014-0131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'In M group, patients will be given oral midazolam 0.5mg/kg upto maximum dose of 15mg (5mg/ml parenteral preparation) mixed with flavored syrup as premedication', 'interventionNames': ['Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'In D group, patients will be given intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg prepared from 100mcg/ml parenteral preparation (Hospira R) . The drug will be administered using a intranasal mucosal administration device (LMA MAD NasalTM).', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'oral midazolam 0.5mg/kg upto maximum dose of 15mg', 'armGroupLabels': ['Midazolam']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': "Children's of Mississippi/University of Mississipi Medical Center", 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Madhankumar Sathyamoorthy, MBBS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Madhankumar Sathyamoorthy', 'investigatorAffiliation': 'University of Mississippi Medical Center'}}}}