Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-29 @ 3:17 AM
Study NCT ID:
NCT00884650
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2009-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000700', 'term': 'Analgesics'}], 'ancestors': [{'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Chang.Frank@tchden.org', 'phone': '720-777-6900', 'title': 'Dr. Frank Chang', 'organization': "Children's Hospital Colorado"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 days', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Analgesia Only', 'description': 'Group 1 will receive oral analgesia only', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'An Anesthetic Infusion Device With Supplement', 'description': 'Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Analgesia Only', 'description': 'Group 1 will receive oral analgesia only'}, {'id': 'OG001', 'title': 'Anesthetic Continuous-Infusion + Oral Analgesia', 'description': 'Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '1.22', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Results of Mean and total Medication administered between the 2 groups over a 4 day period (Mean Medication Administered in mg/kg; SD)', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parent and Patient Satisfaction With the Post Operative Pain Management.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I & Group II', 'description': 'Group I: Allocated to receive oral analgesics only Group II: Anesthetic Continuous Infusion + Oral Analgesia'}], 'classes': [{'title': "Parent felt that pain medicine was able to take away most of their child's pain", 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Parent was "Very Satisfied" with child\'s pain management', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Parent was "Satisfied" with child\'s pain management.', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Parent was "Dissatisfied" with child\'s pain management.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': "Parent would want their child's pain managed in the same way after another surgery", 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 days', 'description': 'Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Arms are combined because no outcome measure data is available for separate arms. We have made multiple attempts to contact the PI and study team to obtain data for separate arms. However, the PI has retired and could not be reached, and the study team either could not be reached, has left the university, or did not have the data. Data is only available for 30 parents.'}, {'type': 'PRIMARY', 'title': 'The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Analgesia Only', 'description': 'Group 1 will receive oral analgesia only'}, {'id': 'OG001', 'title': 'Anesthetic Continuous-Infusion + Oral Analgesia', 'description': 'Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '6.70', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '3.79', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '5.17', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '3.43', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '2.10', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '2.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 days', 'description': 'Pain scores were assessed using a Visual Analog Scale. Possible scores range from 0 (no pain) to 10 (Worst possible pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Analgesia Only', 'description': 'Group 1 will receive oral analgesia only'}, {'id': 'FG001', 'title': 'Anesthetic Continuous-Infusion + Oral Analgesia', 'description': 'Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Did not return complete pain diaries', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Admitted Post-Op', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Femoral Stress Fracture', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pain Pump Complication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Group 1 will receive oral analgesia only'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', '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': '7.1', 'spread': '2.59', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '3.27', 'groupId': 'BG001'}, {'value': '7.89', 'spread': '3.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2009-04-16', 'resultsFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2009-04-20', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-04', 'studyFirstPostDateStruct': {'date': '2009-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.', 'timeFrame': '4 days', 'description': 'Results of Mean and total Medication administered between the 2 groups over a 4 day period (Mean Medication Administered in mg/kg; SD)'}, {'measure': 'The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days.', 'timeFrame': '4 days', 'description': 'Pain scores were assessed using a Visual Analog Scale. Possible scores range from 0 (no pain) to 10 (Worst possible pain).'}], 'secondaryOutcomes': [{'measure': 'Parent and Patient Satisfaction With the Post Operative Pain Management.', 'timeFrame': '4 days', 'description': 'Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Pain management', 'Cerebral Palsy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy.', 'detailedDescription': "A prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or femoral osteotomy metal work removal.\n\nSubjects will be randomized into two groups: the first group will have an anesthetic pain pump device supplemented with oral analgesia and the second group will only receive oral analgesia. The anesthetic continuous device will be used continuously for 48 hours and with a flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. Subjects in both groups will receive oral analgesia according to their pain requirements. The amount of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4 day period. Subjects will have their pain score assessed daily with the use of the Non-Communicating Children's Pain Checklist-Postoperative Version. Their overall satisfaction with post-operative pain management will be assessed at the end of the study with the use of the Parent Total Quality Pain Management questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children with cerebral palsy between 3 and 17 years old.\n* American Society of Anesthesiologists (ASA) intubation grade I, II or III.\n* Ability of subject or primary caregivers to give informed consent, to understand what the study entails and to be able to complete the patient Pain Diary during the post-operative period. Subjects should be available for daily telephone follow-up until the data is completed and they should be able to return the completed Pain Diary to the Primary Investigator.\n* Willingness and understanding of parent or guardian to have their child randomized to receive either the continuous infusion pain pump device or oral analgesics for their child's pain management.\n* English or Spanish-speaking care parent or guardians who are able to complete the Pain Diary.\n\nExclusion Criteria:\n\n* ASA IV or V,\n* Known allergy or sensitivity to bupivacaine,\n* Subjects who will have more than the above mentioned procedure performed during their surgical visit,\n* Subjects with significant kidney or liver disease,\n* Parents/guardians who are assessed by the PI or co-investigators to be unable or unwilling to complete the study's Pain Diary or behavioral tools, and\n* Parents/guardians who are unwilling to allow their child to be randomly assigned to receive either the pain pump with oral analgesics or oral medications alone."}, 'identificationModule': {'nctId': 'NCT00884650', 'briefTitle': 'Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Comparing the Effectiveness of an Anesthetic Continuous-infusion Device to Oral Analgesia in Orthopedic Postoperative Pain Control of Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '04-0981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Analgesic Only', 'description': 'Group 1 will receive oral analgesic only', 'interventionNames': ['Drug: oral analgesic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'anesthetic continuous-infusion + oral analgesia', 'description': 'Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia', 'interventionNames': ['Drug: intravenous analgesic per pump']}], 'interventions': [{'name': 'oral analgesic', 'type': 'DRUG', 'description': 'per clinical standard of care', 'armGroupLabels': ['Oral Analgesic Only']}, {'name': 'intravenous analgesic per pump', 'type': 'DRUG', 'description': 'per clinical standard of care', 'armGroupLabels': ['anesthetic continuous-infusion + oral analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital, Denver", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Frank Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}