Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT00287560
Status:
COMPLETED
Last Update Posted:
2008-02-25
First Post:
2006-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2005-02'}, 'lastUpdateSubmitDate': '2008-02-22', 'studyFirstSubmitDate': '2006-02-06', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of spontaneous expression of pain during injection'}], 'secondaryOutcomes': [{'measure': 'anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events'}]}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia.\n\nStudy hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.', 'detailedDescription': 'Pain on injection is the most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 2 and \\< 6 years\n* written informed consent of the parents\n* anesthetic risc classified as ASA I - III\n* patient undergoing elective surgery under general anesthesia\n* venous access for induction of anesthesia on the dorsum of the hand\n* hospital care for at least 3 hrs after end of anesthesia guaranteed\n\nExclusion Criteria:\n\n* intolerability of the drugs tested\n* current drug medication with sedative effect\n* patient is expected to require concomitant medication not allowed in the study\n* history of or current renal or hepatic disease, cardiac insufficiency\n* hypovolemia\n* increased cranial pressure\n* simultaneous participation in another clinical trial or participation during the month preceding this study'}, 'identificationModule': {'nctId': 'NCT00287560', 'briefTitle': 'Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children', 'orgStudyIdInfo': {'id': 'BBMDE-0312'}}, 'armsInterventionsModule': {'interventions': [{'name': 'propofol (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gerd P Molter, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}}}}