Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-06 @ 11:27 AM
Study NCT ID:
NCT03739567
Status:
UNKNOWN
Last Update Posted:
2019-03-05
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia. A Cross-sectional Study. Rehabilitation Under General Anesthesia
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-02', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-09', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental Discomfort Questionnaire', 'timeFrame': '3 monthes', 'description': 'Numerical Rating Pain Scale (Outcome measuring device)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['General anesthesia, clinical manifestations. .'], 'conditions': ['Post-operative Pain']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is monitoring Postoperative pain in Children Aged from 3 to 5 years following Full mouth Dental Rehabilitation under General Anesthesia', 'detailedDescription': 'The study\'s investigators will record all data related to the immediate postoperative period during the child\'s stay in the post anesthetic recovery room (PAR).\n\nJust prior to discharge home, the child\'s discomfort will be measured using Face, Legs, Activity, Cry, and Consolability Pain Assessment Tool (FLACC).\n\nPostoperative data is collected by the same investigator who contacted caregivers by phone at 4 postoperative times: 1, 3, 7, and 30 days after the DRGA using The Dental Questionnaire.\n\nWhen a participant cannot be reached on the scheduled day, the information is collected on the nearest subsequent day.\n\nThe postoperative assessment included: the questioner and an inquiry about the use of medications; the child\'s ability to eat a regular diet; and "mouth-related" complaints other than dental discomfort.\n\nDental discomfort is assessed in this study by 2 scales:\n\nthe FLACC (Table 1) and The Dental Questioner (Table 2).\n\nFLACC pain assessment tool. The FLACC scale was originally developed to quantify postoperative pain in infants from 2 months old to children up to 7-years-old.(7) This scale assesses 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; and (C) consolability. The range for the total score is from 0 (no pain) to 10 (intense pain). The examiner is standardized to use of the FLACC by a PAR nurse who was experienced in scoring pain with this scale.\n\nThe Dental Questioner. The questionnaire covered the following items: did the Child have pain, bleeding from dental origin, sore throat, fever, vomiting, inability to eat, sleepiness, drowsiness, cough, nausea or psychological changes?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All children attending the outpatients' clinic of pediatric Dentistry and Public Health Faculty of Dentistry Cairo University-Egypt in the period of three months. (With average 30 patients in week ).", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egyptian dental children undergoing full mouth dental rehabilitation under general anesthesia (3-5 years old )\n* Children selected from pediatric dentistry and dental public health department Faculty of dentistry Cairo University\n* Children with no developmental delay.\n* Children with normal physical status.\n* Parents who can be communicated well\n\nExclusion Criteria:\n\n* Parents refusing participation in the study.\n* Parents who cannot be communicated well\n* Children with developmental abnormalities'}, 'identificationModule': {'nctId': 'NCT03739567', 'briefTitle': 'Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia. A Cross-sectional Study. Rehabilitation Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-11-08'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'marwa mostafa ahmed, B.D.S.', 'role': 'CONTACT', 'email': 'marwa.mostafa@dentistry.cu.edu.eg', 'phone': '01003572429'}], 'overallOfficials': [{'name': 'Amr ezzat, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student in Cairo university', 'investigatorFullName': 'Marwa Mostafa Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}