Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00187135
Status:
TERMINATED
Last Update Posted:
2017-04-04
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'referralinfo@stjude.org', 'phone': '866-278-5833', 'title': 'Doralina Anghelescu, MD', 'organization': "St. Jude Children's Research Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'All 162 participants were expected to receive three treatments. Not all participants received all three treatments. Therefore, analysis required the identification of subsets of treated participants. The trial terminated early due to slow accrual.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from the time of procedure up to 7 days post procedure', 'description': "Four participants died during the study period.All 4 deaths were due to the primary disease or complications of the disease process.None of the deaths occurred within 7 days of that patient's procedure for which data was collected, and therefore is unrelated to the study treatment.", 'eventGroups': [{'id': 'EG000', 'title': 'Fentanyl 0.5mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.', 'otherNumAtRisk': 107, 'otherNumAffected': 0, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fentanyl 1mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1.0 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.', 'otherNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.', 'otherNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain(Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl 1mcg/kg vs Placebo', 'description': 'Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.'}, {'id': 'OG001', 'title': 'Fentanyl 0.5mcg/kg vs Placebo', 'description': 'Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.'}], 'classes': [{'title': 'Pain with Fentanyl and pain with Placebo', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Pain with Fentanyl and no-pain with Placebo', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'No-pain with Fentanyl pain with Placebo', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'No-pain with Fentanyl no-pain with Placebo', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG001'], 'ciPctValue': '95', 'pValueComment': 'To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.', 'groupDescription': 'The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.', 'groupDescription': 'The study was designed to achieve statistical power of 80% for this comparison. The sample size needed to ensure adequate statistical power for this comparison was obtained.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score \\>0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant\'s procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.'}, {'type': 'PRIMARY', 'title': 'Pain (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl 0.5mcg/kg vs Fentanyl 1mcg/kg', 'description': 'Patients who completed treatment with Fentanyl 0.5 mcg/kg and Fentanyl 1mcg/kg.'}], 'classes': [{'title': 'Pain on Fentanyl (1), Pain on Fentanyl (0.5)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pain on Fentanyl (1) No-pain on Fentanyl (0.5)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'No-Pain on Fentanyl (1), Pain on Fentanyl (0.5)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'No-Pain on Fentanyl (1), No-Pain on Fentanyl (0.5)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000'], 'ciPctValue': '95', 'pValueComment': 'To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.', 'groupDescription': 'The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score \\>0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant\'s procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.'}, {'type': 'SECONDARY', 'title': '20% or Greater Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl 0.5mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG001', 'title': 'Fentanyl 1mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in heart rate (HR) on pain (Y/N) while controlling for treatment.', 'statisticalMethod': 'GEE Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.'}, {'type': 'SECONDARY', 'title': '20% or Greater Change in Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl 0.5mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG001', 'title': 'Fentanyl 1mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in respiratory rate (RR) on pain (Y/N) while controlling for treatment.', 'statisticalMethod': 'GEE Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.'}, {'type': 'SECONDARY', 'title': '20% or Greater Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl 0.5mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG001', 'title': 'Fentanyl 1mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in blood presure (BP) on pain (Y/N) while controlling for treatment.', 'statisticalMethod': 'GEE Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.'}, {'type': 'SECONDARY', 'title': 'Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fentanyl 0.5mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG001', 'title': 'Fentanyl 1mcg/kg', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of motion (Y/N)on pain (Y/N) while controlling for treatment.', 'statisticalMethod': 'GEE Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Movement (yes/no) measured during recovery after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fentanyl 0.5 / Placebo / Fentanyl 1', 'description': 'Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit.'}, {'id': 'FG001', 'title': 'Fentanyl 0.5 /Fentanyl 1 / Placebo', 'description': 'Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.'}, {'id': 'FG002', 'title': 'Placebo / Fentanyl 0.5 /Fentanyl 1', 'description': 'Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit.'}, {'id': 'FG003', 'title': 'Placebo /Fentanyl 1 / Fentanyl 0.5', 'description': 'Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.'}, {'id': 'FG004', 'title': 'Fentanyl 1 / Fentanyl 0.5 / Placebo', 'description': 'Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.'}, {'id': 'FG005', 'title': 'Fentanyl 1 / Placebo /Fentanyl 0.5', 'description': 'Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.'}], 'periods': [{'title': 'Visit One', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Visit Two', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Study Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}]}, {'title': 'Visit Three', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Study Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'A total of 168 participants were enrolled between March, 2002 and August, 2007.', 'preAssignmentDetails': '168 participants were enrolled and were expected to receive 3 Bone Marrow Aspirations/Lumbar Puncture Intrathecal Chemotherapy procedures; 6 patients withdrew (eg: medical withdrawal, withdrawal of consent and other). 162 were randomized, of which 77 completed all 3 treatments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '162', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Fentanyl 0.5/Placebo/Fentanyl 1'}, {'id': 'BG001', 'title': 'Fentanyl 0.5/Fentanyl 1/Placebo'}, {'id': 'BG002', 'title': 'Placebo/Fentanyl 0.5/Fentanyl 1'}, {'id': 'BG003', 'title': 'Placebo/Fentanyl 1/Fentanyl 0.5'}, {'id': 'BG004', 'title': 'Fentanyl 1/Fentanyl 0.5/Placebo'}, {'id': 'BG005', 'title': 'Fentanyl 1/Placebo/Fentanyl 0.5'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '7.6', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '7.1', 'spread': '4.1', 'groupId': 'BG003'}, {'value': '7.3', 'spread': '4.7', 'groupId': 'BG004'}, {'value': '7.1', 'spread': '4.4', 'groupId': 'BG005'}, {'value': '7.1', 'spread': '4.4', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'All 162 participants who enrolled and were randomized on the study are included in the baseline summary statistics.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All 162 participants who enrolled and were randomized on the study are included in the baseline summary statistics.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'whyStopped': 'The study was terminated due to slow accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2009-10-13', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-03-04', 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain(Yes/No)', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score \\>0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant\'s procedure.'}, {'measure': 'Pain (Yes/No)', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score \\>0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant\'s procedure.'}], 'secondaryOutcomes': [{'measure': '20% or Greater Change in Heart Rate', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.'}, {'measure': '20% or Greater Change in Respiratory Rate', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.'}, {'measure': '20% or Greater Change in Blood Pressure', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.'}, {'measure': 'Movement', 'timeFrame': 'The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.', 'description': 'Movement (yes/no) measured during recovery after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain Management', 'Bone Marrow Aspiration'], 'conditions': ['Bone Marrow Disease', 'Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}]}, 'descriptionModule': {'briefSummary': "St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed, will provide better pain control.\n\nEach patient enrolled on this study will have three different anesthetic combinations for three different procedures, in order to determine which combination worked best for each child.", 'detailedDescription': 'The study focusses on the following primary aims:\n\n* To compare 0.5 mg/kg versus 1.0 mg/kg of fentanyl to control pain in patients who have a BMT/LPIT procedure in the context of propofol anesthesia and topical anesthesia with EMLA or L•M•X 4™cream (or when necessary, lidocaine for injection).\n* To compare placebo versus fentanyl (0.5 mg/kg or 1.0 mg/kg) in these same patients. The first BMT/LPIT for which patients receive any fentanyl will be used in this comparison.\n\nThe study focusses on the following secondary aims:\n\n* To determine which dose regimen ensures best conditions to perform bone marrow aspiration (lack of motion) and maintains hemodynamic and respiratory stability as indicators of adequate levels of analgesia during bone marrow aspiration.\n* To evaluate the safety and complications for each dose regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing bone marrow aspiration (unilateral), with lumbar puncture and intrathecal chemotherapy.\n* Age 2 to 17 years\n* ASA I-III\n* Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma in remission or on the day of anticipated remission procedures occurring at the end of remission induction.\n* Patients must have three anticipated bone marrow aspirates and lumbar punctures with intrathecal chemotherapy remaining in their treatment\n\nExclusion Criteria:\n\n* Newly diagnosed patients\n* Patients with low platelet count (less than 50000)\n* Patients undergoing bone marrow biopsy in addition to bone marrow aspiration\n* Age less than 2 years or over 17 years\n* ASA IV-V\n* Patients taking opioid medication for pre-existent pain for more than 2 weeks at the time of the procedure\n* Neurological impairment that would increase susceptibility to opioids (Down's syndrome)\n* Clinical contraindications for general anesthesia (large mediastinal mass) or specific use of propofol, Fentanyl, EMLA, L•M•X 4™ or Lidocaine for injection"}, 'identificationModule': {'nctId': 'NCT00187135', 'briefTitle': 'Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Fentanyl-Propofol-EMLA or L.M.X4™ Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study', 'orgStudyIdInfo': {'id': 'PFE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Fentanyl-1mcg/kg in 3 ml of Normal Saline', 'interventionNames': ['Drug: Fentanyl', 'Drug: EMLA', 'Drug: L.M.X4', 'Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Fentanyl - 0.5 mcg/kg in 3 ml normal saline', 'interventionNames': ['Drug: Fentanyl', 'Drug: EMLA', 'Drug: L.M.X4', 'Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'normal saline', 'interventionNames': ['Drug: EMLA', 'Drug: L.M.X4', 'Drug: Propofol']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': '1. Fentanyl - 1 mcg/kg in 3 ml normal saline\n2. Fentanyl - 0.5 mcg/kg in 3 ml normal saline', 'armGroupLabels': ['1', '2']}, {'name': 'EMLA', 'type': 'DRUG', 'description': 'All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours.', 'armGroupLabels': ['1', '2', '3']}, {'name': 'L.M.X4', 'type': 'DRUG', 'description': 'All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes.', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Doralina L. Anghelescu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}