Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 4:48 AM
Study NCT ID:
NCT03854604
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2019-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-30', 'studyFirstSubmitDate': '2019-02-16', 'studyFirstSubmitQcDate': '2019-02-23', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Correlation between postoperative (Children's Hospital of Eastern Ontario Scale ) CHEOPS score and postoperative perfusion index.", 'timeFrame': 'the time span between arrival to PACU and for at least two hours postoperative'}], 'secondaryOutcomes': [{'measure': 'validity of perfusion index to predict postoperative pain and the need of rescue analgesia', 'timeFrame': 'he time span between arrival to PACU and for at least two hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '33891250', 'type': 'DERIVED', 'citation': 'Ahmed A, Lotfy A, Elkholy J, Abdelhamid B, Ollaek M. Perfusion index as an objective measure of postoperative pain in children undergoing adenotonsillectomy: a cohort study. J Clin Monit Comput. 2022 Jun;36(3):795-801. doi: 10.1007/s10877-021-00710-3. Epub 2021 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'It has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult.\n\nPerfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. PI can represent the peripheral perfusion dynamics due to change of peripheral vasomotor tone. Low PI values suggest peripheral vasoconstriction and high PI values suggest peripheral vasodilation.\n\nThe sympathetic nervous system is inherently involved in the pathophysiological responses evoked by painful stimulation.\n\nIn the current study, investigators hypothesise that the PI could be a good objective tool for assessment of postoperative pain in children undergoing adenotonsillectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 3-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ASA physical status I-II\n2. Age 3 to 7 years\n3. Children undergoing adenotonsillectomy.\n\nExclusion Criteria:\n\n1. Parents' refusal.\n2. Children with behavioral changes\n3. Children with physical developmental delay\n4. Children on treatment with sedative or anticonvulsant."}, 'identificationModule': {'nctId': 'NCT03854604', 'briefTitle': 'Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients Undergoing Adenotonsillectomy. An Observational Study.', 'orgStudyIdInfo': {'id': 'N-110-2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'postoperative pain assessment', 'type': 'OTHER', 'description': 'evaluation of the efficacy of PI as an objective measure for postoperative pain assessment in pediatric population undergoing adenotonsillectomy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '002211', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Abeer Ahmed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '00225', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy Faculty of Medicine - Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Anesthesia department - Faculty of medicine- Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine', 'investigatorFullName': 'Abeer Ahmed, MD', 'investigatorAffiliation': 'Cairo University'}}}}