Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04820205
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2021-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D002697', 'term': 'Chloral Hydrate'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-05', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes %', 'timeFrame': 'During pediatric procedural sedation (up to 1 hour)', 'description': 'Success rate of adequate sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %'}], 'secondaryOutcomes': [{'measure': 'Onset time of sedation (PSSS= 0,1,2,3) (min)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration.'}, {'measure': 'Duration of sedation = Recovery time (PSSS= 4,5) (min)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'Pediatric Sedation State Scale= 4,5 after recovery of sedation'}, {'measure': 'PSSS(Pediatric Sedation State Scale, 0-5)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': '5 Patient is moving in a manner that impedes the proceduralist and requires forceful immobilization.\n\n4 Moving during the procedure that requires gentle immobilization for positioning.\n\n3 Expression of pain or anxiety on face, but not moving or impeding completion of the procedure.\n\n2 Quiet (asleep or awake), not moving during procedure, and no frown (or brow furrow) indicating pain or anxiety.\n\n1 Deeply asleep with normal vital signs, but requiring airway intervention and/or assistance 0 Sedation associated with abnormal physiologic parameters that require acute intervention q 10min'}, {'measure': 'Heart rate during sedation (/min)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'HR(/min) at Baseline(T0), q 10min'}, {'measure': 'SpO2 during sedation (%)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'SpO2(%) by pulse oximetry at Baseline(T0), q 10min'}, {'measure': 'Respiratory rate during sedation (/min)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'RR(/min) at Baseline(T0), q 10min'}, {'measure': 'the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %'}, {'measure': 'The incidence of respiratory intervention: Manual ventilation or Artificial airway %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'The incidence of respiratory intervention: Manual ventilation or Artificial airway'}, {'measure': 'The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'The incidence of significant desaturation (SpO2 \\< 95% or -10% from baseline, \\>10 seconds) %'}, {'measure': 'The incidence of significant apnea (>20seconds) %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'The incidence of significant apnea (\\>20seconds) %'}, {'measure': 'The lowest SpO2 value (%)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'The lowest SpO2 value (%)'}, {'measure': 'The incidence of hemodynamic intervention: fluid management, intravenous medication %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'The incidence of hemodynamic intervention: fluid management, intravenous medication %'}, {'measure': 'The incidence of significant bradycardia (-30% from baseline) %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'The incidence of significant bradycardia (-30% from baseline) %'}, {'measure': 'The incidence of significant hypotension (-30% from baseline) %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'The incidence of significant hypotension (-30% from baseline) %'}, {'measure': "Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)", 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': "Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)"}, {'measure': 'Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)'}, {'measure': "Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)", 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': "Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)"}, {'measure': 'The incidence of other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)'}, {'measure': 'The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min %', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'Failure of adequate sedation (PSSS= 0, 4,5) after 30 min %'}, {'measure': 'The incidence of completion of procedure', 'timeFrame': 'During pediatric procedural sedation (up to 3 hour)', 'description': 'Completion of procedure'}, {'measure': 'Total cost of sedation (KRW), optional', 'timeFrame': 'During pediatric procedural sedation (up to 1 day)', 'description': 'Total cost of sedation (KRW), if applicable'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'procedural sedation', 'chloral hydrate', 'intranasal dexmedetomidine', 'intranasal ketamine'], 'conditions': ['Sedation']}, 'referencesModule': {'references': [{'pmid': '26714442', 'type': 'BACKGROUND', 'citation': 'Zhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30.'}, {'pmid': '28414899', 'type': 'BACKGROUND', 'citation': 'Cao Q, Lin Y, Xie Z, Shen W, Chen Y, Gan X, Liu Y. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth. 2017 Jun;27(6):629-636. doi: 10.1111/pan.13148. Epub 2017 Apr 17.'}, {'pmid': '24237879', 'type': 'BACKGROUND', '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': '25822924', 'type': 'BACKGROUND', 'citation': 'Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.'}, {'pmid': '27627818', 'type': 'BACKGROUND', 'citation': 'Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353.'}, {'pmid': '28639236', 'type': 'BACKGROUND', 'citation': 'Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.'}, {'pmid': '30032884', 'type': 'BACKGROUND', 'citation': 'Abdel-Ghaffar HS, Kamal SM, El Sherif FA, Mohamed SA. Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy. Br J Anaesth. 2018 Aug;121(2):445-452. doi: 10.1016/j.bja.2018.03.039. Epub 2018 Jun 22.'}, {'pmid': '28319161', 'type': 'BACKGROUND', 'citation': 'Poonai N, Canton K, Ali S, Hendrikx S, Shah A, Miller M, Joubert G, Rieder M, Hartling L. Intranasal ketamine for procedural sedation and analgesia in children: A systematic review. PLoS One. 2017 Mar 20;12(3):e0173253. doi: 10.1371/journal.pone.0173253. eCollection 2017.'}, {'pmid': '36597163', 'type': 'DERIVED', 'citation': 'Jang YE, Joo EY, Lee JH, Kim EH, Kang P, Park JB, Kim HS, Kim JT. Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol. Trials. 2023 Jan 3;24(1):2. doi: 10.1186/s13063-022-07033-x.'}]}, 'descriptionModule': {'briefSummary': 'In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the first-attempt success rate of pediatric procedural sedation. The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of adequate pediatric procedural sedation (PSSS=1,2,3) within 15 minutes. This is a prospective, parallel-arm, single-blinded, multi-center, randomized controlled trial comparing the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) with oral chloral hydrate (50mg/kg) in pediatric patients undergoing procedural sedation. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients who need procedural sedation (Age \\< 7 years)\n* ASA (American Society of Anesthesiologists) physical status 1-3\n\nExclusion Criteria:\n\n* ASA (American Society of Anesthesiologists) physical status 4-5\n* History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate\n* Recent administration of Alpha 2 adrenergic receptor agonist or antagonist\n* Cannot administrate oral medication (e.g. Swallowing difficulty)\n* Cannot administrate intranasal medication(e.g. Excessive rhinorrhea)\n* Unstable vital signs, Unstable arrhythmia'}, 'identificationModule': {'nctId': 'NCT04820205', 'briefTitle': 'Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IN DEXKET first'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intranasal dexmedetomdine and kemtaine', 'description': 'Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)', 'interventionNames': ['Drug: Intranasal dexmedetomidine and ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oral chloral hydrate', 'description': 'Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)', 'interventionNames': ['Drug: Oral chloral hydrate']}], 'interventions': [{'name': 'Intranasal dexmedetomidine and ketamine', 'type': 'DRUG', 'description': 'Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)', 'armGroupLabels': ['intranasal dexmedetomdine and kemtaine']}, {'name': 'Oral chloral hydrate', 'type': 'DRUG', 'description': 'Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)', 'armGroupLabels': ['oral chloral hydrate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jin-Tae Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}