Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-03-28 @ 11:00 AM
Study NCT ID:
NCT00596050
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2008-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions
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': 'D007649', 'term': 'Ketamine'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005045', 'term': 'Etomidate'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D008012', 'term': 'Lidocaine'}], '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': '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'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2008-01-07', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OSBD-r', 'timeFrame': 'immediate', 'description': 'Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.'}], 'secondaryOutcomes': [{'measure': 'Likert satisfaction scale', 'timeFrame': 'immediate', 'description': 'Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.'}, {'measure': 'procedural recall', 'timeFrame': 'immediate', 'description': 'Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['procedural sedation', 'fracture reduction', 'pediatric emergency medicine', 'etomidate', 'ketamine', 'analgesia'], 'conditions': ['Conscious Sedation Failure During Procedure']}, 'referencesModule': {'references': [{'pmid': '15829394', 'type': 'BACKGROUND', 'citation': 'Bahn EL, Holt KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin North Am. 2005 May;23(2):503-17. doi: 10.1016/j.emc.2004.12.013.'}, {'pmid': '9755272', 'type': 'BACKGROUND', 'citation': 'Kennedy RM, Porter FL, Miller JP, Jaffe DM. Comparison of fentanyl/midazolam with ketamine/midazolam for pediatric orthopedic emergencies. Pediatrics. 1998 Oct;102(4 Pt 1):956-63. doi: 10.1542/peds.102.4.956.'}, {'pmid': '11310461', 'type': 'BACKGROUND', 'citation': 'Acworth JP, Purdie D, Clark RC. Intravenous ketamine plus midazolam is superior to intranasal midazolam for emergency paediatric procedural sedation. Emerg Med J. 2001 Jan;18(1):39-45. doi: 10.1136/emj.18.1.39.'}, {'pmid': '8669740', 'type': 'BACKGROUND', 'citation': 'Gerardi MJ, Sacchetti AD, Cantor RM, Santamaria JP, Gausche M, Lucid W, Foltin GL. Rapid-sequence intubation of the pediatric patient. Pediatric Emergency Medicine Committee of the American College of Emergency Physicians. Ann Emerg Med. 1996 Jul;28(1):55-74. doi: 10.1016/s0196-0644(96)70140-3.'}, {'pmid': '11136141', 'type': 'BACKGROUND', 'citation': 'Ruth WJ, Burton JH, Bock AJ. Intravenous etomidate for procedural sedation in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):13-8. doi: 10.1111/j.1553-2712.2001.tb00539.x.'}, {'pmid': '12023700', 'type': 'BACKGROUND', 'citation': 'Vinson DR, Bradbury DR. Etomidate for procedural sedation in emergency medicine. Ann Emerg Med. 2002 Jun;39(6):592-8. doi: 10.1067/mem.2002.123695.'}, {'pmid': '11136155', 'type': 'BACKGROUND', 'citation': 'Dickinson R, Singer AJ, Carrion W. Etomidate for pediatric sedation prior to fracture reduction. Acad Emerg Med. 2001 Jan;8(1):74-7. doi: 10.1111/j.1553-2712.2001.tb00558.x.'}, {'pmid': '11136139', 'type': 'BACKGROUND', 'citation': 'Schenarts CL, Burton JH, Riker RR. Adrenocortical dysfunction following etomidate induction in emergency department patients. Acad Emerg Med. 2001 Jan;8(1):1-7. doi: 10.1111/j.1553-2712.2001.tb00537.x.'}, {'pmid': '12837876', 'type': 'BACKGROUND', 'citation': 'Godambe SA, Elliot V, Matheny D, Pershad J. Comparison of propofol/fentanyl versus ketamine/midazolam for brief orthopedic procedural sedation in a pediatric emergency department. Pediatrics. 2003 Jul;112(1 Pt 1):116-23. doi: 10.1542/peds.112.1.116.'}, {'pmid': '1026900', 'type': 'BACKGROUND', 'citation': 'Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.'}, {'pmid': '12013357', 'type': 'BACKGROUND', 'citation': 'Keim SM, Erstad BL, Sakles JC, Davis V. Etomidate for procedural sedation in the emergency department. Pharmacotherapy. 2002 May;22(5):586-92. doi: 10.1592/phco.22.8.586.33204.'}, {'pmid': '15459618', 'type': 'BACKGROUND', 'citation': 'Mace SE, Barata IA, Cravero JP, Dalsey WC, Godwin SA, Kennedy RM, Malley KC, Moss RL, Sacchetti AD, Warden CR, Wears RL; American College of Emergency Physicians. Clinical policy: evidence-based approach to pharmacologic agents used in pediatric sedation and analgesia in the emergency department. Ann Emerg Med. 2004 Oct;44(4):342-77. doi: 10.1016/j.annemergmed.2004.04.012. No abstract available.'}, {'type': 'BACKGROUND', 'citation': "Jay SM, Ozolins M, Elliott C, Caldwell S. Assessment of children's distress during painful medical procedures. J Health Psycho. 1983; 2: 133-147"}]}, 'descriptionModule': {'briefSummary': 'There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.', 'detailedDescription': 'There are multiple retrospective studies detailing the use of etomidate in pediatric procedural sedation but few to no prospective clinical trials. None have compared etomidate to ketamine, currently the most commonly used sedative in the emergency department for pediatric procedural sedation. The investigators propose a randomized, controlled trial comparing etomidate versus ketamine for procedural sedation for fracture reduction for children presenting with extremity fracture requiring sedation for reduction. The investigators hypothesize that etomidate in combination with fentanyl will have similar reduction of distress and procedural recall as ketamine in combination with midazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 5-18 years\n* extremity fracture requiring reduction with sedation in emergency department\n\nExclusion Criteria:\n\n* allergy to etomidate, midazolam, fentanyl, ketamine, lidocaine\n* multi-system trauma\n* history of psychosis\n* pregnancy\n* illicit drug use\n* developmental delay\n* non-english speaker'}, 'identificationModule': {'nctId': 'NCT00596050', 'briefTitle': 'Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions', 'organization': {'class': 'OTHER', 'fullName': 'Drexel University'}, 'officialTitle': 'Ketamine Versus Etomidate for Procedural Sedation for Pediatric Orthopedic Reductions', 'orgStudyIdInfo': {'id': '16271'}, 'secondaryIdInfos': [{'id': 'Project No 1041266', 'type': 'OTHER', 'domain': 'drexel'}, {'id': 'Action No 47488', 'type': 'OTHER', 'domain': 'drexel'}, {'id': 'Detail No 240976', 'type': 'OTHER', 'domain': 'drexel'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine and midazolam', 'description': 'ketamine and midazolam', 'interventionNames': ['Drug: ketamine and midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'etomidate and fentanyl and lidocaine', 'description': 'etomidate and fentanyl and lidocaine', 'interventionNames': ['Drug: etomidate, fentanyl, and lidocaine']}], 'interventions': [{'name': 'ketamine and midazolam', 'type': 'DRUG', 'description': 'ketamine 1 mg/kg/dose, midazolam 0.05 mg/kg/dose max 2 mg', 'armGroupLabels': ['ketamine and midazolam']}, {'name': 'etomidate, fentanyl, and lidocaine', 'type': 'DRUG', 'description': 'etomidate 0.2 mg/kg/dose, fentanyl 1 microgram/kg/dose, lidocaine 0.5 mg/kg/dose', 'armGroupLabels': ['etomidate and fentanyl and lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jannet J Lee-Jayaram, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drexel University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}