Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:43 PM
Study NCT ID:
NCT04156334
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2019-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Concealed randomisation table where patients will be consecutively assigned. Every patient will be given a number according to the randomisation table and the study group inclusion will not be revealed to the investigator or patients until the end of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The double-blinded prospective randomised study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Pain scores before and over 48 hours after tooth extraction in general anaesthesia in the two study groups using The Children's Hospital of Eastern Ontario Pain over Scale (CHEOPS)", 'timeFrame': 'an average 51 hours (monitoring of pain will be performed one hour before the general anesthesia treatment, 2 hours after treatment, 12 hours after treatment, 24 and 48 hours after treatment', 'description': "Monitoring's the pain with CHEOPS which evaluates crying, face expression, speech, body movement, touching of the painful area and leg movement. Each category has specific points according to the level of behaviour. Points are added and final scores range between 4-13 points. The number of scores at different measuring points before and over 48 hours after treatment will be compared between the two study groups."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '30143396', 'type': 'RESULT', 'citation': 'Patini R, Staderini E, Cantiani M, Camodeca A, Guglielmi F, Gallenzi P. Dental anaesthesia for children - effects of a computer-controlled delivery system on pain and heart rate: a randomised clinical trial. Br J Oral Maxillofac Surg. 2018 Oct;56(8):744-749. doi: 10.1016/j.bjoms.2018.08.006. Epub 2018 Aug 22.'}, {'pmid': '20020791', 'type': 'RESULT', 'citation': 'Townsend JA, Ganzberg S, Thikkurissy S. The effect of local anesthetic on quality of recovery characteristics following dental rehabilitation under general anesthesia in children. Anesth Prog. 2009 Winter;56(4):115-22. doi: 10.2344/0003-3006-56.4.115.'}]}, 'descriptionModule': {'briefSummary': "Use of local anaesthesia during full mouth dental rehabilitation under general anaesthesia is an everyday practice. It enables better control of the post-extraction bleeding and better control of physiological responses. Postoperative numbness and lip and cheek biting can be an undesired side effect. With our research, we aim to compare two different types of local anaesthesia in relation to postoperative side effects. We also aim to assess the oral health-related quality of life after treatment in general anaesthesia to enlighten how full mouth rehabilitation affects a child's life.", 'detailedDescription': "Dental treatment of children under general anaesthesia (GA) is intended for children who, for one reason or another, are unable to participate in the outpatient clinic.\n\nWhen extracting teeth in GA, local anaesthetics (LA) are regularly applied to control bleeding, reduce postoperative sensitivity, and to better control vital functions. The side effects of LA can be the patient's irritation due to not understanding the postoperative numbness and lip and cheek biting.\n\nThe aim of our study is to determine if there is a difference between the two types of local anaesthesia (computer-controlled intraosseous anaesthesia and classical local/conductive anaesthesia) in the frequency and extent of the occurrence of side effects postoperatively.\n\nThe research data would help establish a better dental extraction protocol for children under GA, which would allow for less postoperative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Paediatric patients intended for dental treatment in general anaesthesia\n\nExclusion Criteria:\n\n* Patients who can not express feelings adequately,\n* patients where there will not be any teeth extracted,\n* patients whose parents do not want to participate in the study'}, 'identificationModule': {'nctId': 'NCT04156334', 'briefTitle': 'The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Ljubljana'}, 'officialTitle': "The Effect of Two Local Anaesthesia Techniques on the Paediatric Patient's Recovery After Dental Treatment in General Anaesthesia", 'orgStudyIdInfo': {'id': '2019/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'computer-controlled intraosseous anaesthesia', 'description': 'Patients will receive the local anaesthetic using computer-controlled intraosseous anaesthesia (Quicksleeper 5) before the tooth extraction in general anaesthesia.', 'interventionNames': ['Procedure: Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'infiltrative or conductive local anaesthesia', 'description': 'Patients will receive a local anaesthetic using carpule before the tooth extraction in general anaesthesia.', 'interventionNames': ['Procedure: Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia']}], 'interventions': [{'name': 'Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia', 'type': 'PROCEDURE', 'description': 'QuickSleeper 5 with DHT needles or carpule with periapical/nerve block needles will be used to administer local anaesthetic before teeth extraction in general anaesthesia.', 'armGroupLabels': ['computer-controlled intraosseous anaesthesia', 'infiltrative or conductive local anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University medical centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Rok Gašperšič, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Ljubljana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'non'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}