Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 8:13 PM
Study NCT ID:
NCT05445856
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2022-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'On arrival at the post-anesthesia care unit', 'description': 'Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes)'}, {'measure': 'Opioid consumption', 'timeFrame': 'First 5 postoperative days', 'description': 'Cumulative postoperative opioid consumption in morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '1, 2, 3, 5 and 7 days after surgery', 'description': 'Pain at swallowing (numeric rating scale (NRS) 0-10, lower scores are better outcomes)'}, {'measure': 'Opioid consumption', 'timeFrame': '1 and 7 days after surgery', 'description': 'Cumulative postoperative opioid consumption in morphine equivalents'}, {'measure': 'Postoperative nausea and vomiting (none, mild, moderate, severe)', 'timeFrame': '1, 2 and 3 days after surgery', 'description': 'Nausea and/or vomiting (PONV), proportion of patients with none or mild PONV'}, {'measure': 'Sedation', 'timeFrame': '4 hours after surgery', 'description': 'Level of sedation (Ramsay Scale (1-4)), proportion of patients being co-operative, oriented and tranquil'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Methadone'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '28418966', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.'}, {'pmid': '25837528', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.'}, {'pmid': '20418538', 'type': 'BACKGROUND', 'citation': 'Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.'}, {'pmid': '22063370', 'type': 'BACKGROUND', 'citation': 'Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages.'}, {'pmid': '40502985', 'type': 'DERIVED', 'citation': 'Bondergaard M, Uhrbrand PG, Karaca T, Rhode M, Kjaergaard T, Svendsen RT, Klug TE, Nikolajsen L, Friesgaard KD. Intraoperative methadone for postoperative pain in adult patients undergoing tonsillectomy-a randomised controlled trial. BJA Open. 2025 May 26;14:100418. doi: 10.1016/j.bjao.2025.100418. eCollection 2025 Jun.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial evaluating the efficacy and safety of single-shot intraoperative methadone for postoperative pain in patients undergoing tonsillectomy. Fentanyl is used as an active comparator', 'detailedDescription': 'This study is an investigator-initiated, prospective, randomised controlled trial with two arms: an intervention arm (methadone) and a control arm (fentanyl). Patients scheduled for tonsillectomy at Randers Regional Hospital, Denmark, will be approached for study participation.\n\nPatients are randomised in a 1:1 ratio in blocks of varying sizes (between 4 and 8) to receive either intraoperative methadone or fentanyl. The randomisation assignment will be handled by the hospital pharmacy using a web-based central randomisation procedure (www.sealedenvelope.com).\n\nThe study drug will be prepared by the hospital pharmacy at Aarhus University Hospital and delivered as kits with identical appearance, marked with the randomization number (1-130). On the day of surgery, a kit will be opened and a 10 ml syringe with study drug (methadone 2 mg/ml or fentanyl 30 microgram/ml or ) will prepared by a health care professional (nurse or medical doctor not involved in the study or the treatment of patients). Once prepared, the blinded study drug will be given to and handled by one of the research team members and administered after induction of anesthesia and prior to surgery\n\nThe dose of the study drug will be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg / 3 μg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (women: height (cm) - 105. Men: height (cm) - 100)) after induction of anaesthesia and before the start of surgery.\n\nPostoperative data will be obtained by reviewing hospital records, by interview and electronic questionnaires sent by email.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients (≥18 years) scheduled for elective tonsillectomy\n\nExclusion Criteria:\n\n* American Society of Anaesthesiologists (ASA) physical status IV or V\n* Allergy to study drugs\n* Daily use of opioids 7 days prior to surgery\n* Inability to provide informed consent\n* Severe respiratory insufficiency\n* Heart failure\n* Acute alcohol intoxication/delirium tremens\n* Increased intracranial pressure\n* Acute liver disease\n* Liver insufficiency\n* Kidney insufficiency\n* Treatment with rifampicin\n* Treatment with any drug prolonging the QT-interval\n* Pregnancy (every female not using contraceptives will be screened with urine human choriogonadotropin)\n* Breastfeeding'}, 'identificationModule': {'nctId': 'NCT05445856', 'acronym': 'METATONS', 'briefTitle': 'Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Intraoperative Methadone for Postoperative Pain in Patients Undergoing Tonsillectomy - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022-002496-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methadone', 'description': 'Single-shot intravenous methadone 0.2 mg/kg administered intraoperatively', 'interventionNames': ['Drug: Methadone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl', 'description': 'Single-shot intravenous fentanyl 3 microgram/kg administered intraoperatively', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'description': 'Methadone is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery', 'armGroupLabels': ['Methadone']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl is administered as a single intravenous dose after induction of anesthesia and prior to initiation of surgery', 'armGroupLabels': ['Fentanyl']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Randers', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Michael Bøndergaard, MD', 'role': 'CONTACT', 'email': 'michael.vinther@gmail.com', 'phone': '51326539'}], 'facility': 'Department of Anaesthesiology and Intensive Care', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}], 'centralContacts': [{'name': 'Michael Bøndergaard, MD', 'role': 'CONTACT', 'email': 'michael.vinther@gmail.com', 'phone': '004578420510'}, {'name': 'Kristian Friesgaard, MD, PhD', 'role': 'CONTACT', 'email': 'k.friesgaard@me.com', 'phone': '00457842332'}], 'overallOfficials': [{'name': 'Lone Nikolajsen, PhD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital, Department of Anesthesia and Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be shared upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}