Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-31 @ 5:53 AM
Study NCT ID:
NCT00477061
Status:
COMPLETED
Last Update Posted:
2007-05-22
First Post:
2007-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morphine Analgesia in Patients With Acute Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-20', 'studyFirstSubmitDate': '2007-05-20', 'studyFirstSubmitQcDate': '2007-05-20', 'lastUpdatePostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Accuracy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MORPHINE', 'ANALGESIA', 'ACUTE APPENDICITS'], 'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '18723709', 'type': 'DERIVED', 'citation': 'Amoli HA, Golozar A, Keshavarzi S, Tavakoli H, Yaghoobi A. Morphine analgesia in patients with acute appendicitis: a randomised double-blind clinical trial. Emerg Med J. 2008 Sep;25(9):586-9. doi: 10.1136/emj.2007.050914.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.', 'detailedDescription': 'Analgesic administration for pain control in patients with acute abdominal pain, regarding acute appendicitis, is controversial. Despite the results previous studies indicating the safeness of analgesic use in ED for acute abdominal pain, physicians still prefer to postpone their use after performing surgical evaluations. Since many patients admitted to ED are unlikely to receive prompt surgical consultation, many of them need pain relief to prevent unnecessary suffering. On the other hand such pain relief must not interfere with the diagnosis and treatment of patients and do not cause any complications. Morphine is a common and effective analgesic which, if shown to have no effect on correct diagnosis of acute abdomen, can be used for this purpose.\n\nThus we evaluated morphine effect on pain reduction and diagnostic accuracy in patients admitted to ED with the diagnosis of acute appendicitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical signs of acute appendicitis\n* planned for appendectomy\n* supposed to wait for at least 1 hour in the ED before operation\n\nExclusion Criteria:\n\n* suspicion to perforated appendicitis\n* being under the age of 13\n* pregnancy (according to history and ß-HCG result)\n* opium addiction\n* systolic blood pressure of less than 90 mmHG\n* known cases of chronic obstructive pulmonary disease (COPD)\n* known sensitivity to morphine\n* history of sickle cell disease\n* self administration of analgesics before enrollment\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT00477061', 'briefTitle': 'Morphine Analgesia in Patients With Acute Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Double Blind Randomized Study of Morphine Analgesia in Patients With Acute Appendicitis', 'orgStudyIdInfo': {'id': 'AG11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Morphine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Sina General Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Asieh Golozar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}}}}