Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 9:45 PM
Study NCT ID:
NCT07452705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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'}, {'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], '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'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-02-01', 'size': 345579, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-16T21:20', 'hasProtocol': True}, {'date': '2026-02-01', 'size': 180106, 'label': 'Informed Consent Form: Consent form from parent or guardian.', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-16T19:02', 'hasProtocol': False}, {'date': '2026-02-01', 'size': 118315, 'label': 'Informed Consent Form: Consent form from adolescent patient.', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-16T18:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Informed consent (and assent where appropriate) will be obtained pre- operatively. An independent statistician will generate a computerised sequence in blocks of four. Sequentially-numbered opaque sealed envelopes (SNOSE; n = 114) will assign patients 1:1 to:\n\n* Group A Ketamine-Morphine PCA (K-M)\n* Group B Morphine-only PCA (M)\n\nAn Acute Pain Service (APS) nurse not otherwise involved in the study will prepare identically labelled 30 mL polypropylene syringes (patient name + study ID only). Investigators, ward staff, surgeons and patients will remain blinded. In recovery, Group A receives a ketamine-morphine PCA solution (1 mg mL-¹ + 1 mg mL-¹); Group B receives morphine alone (1 mg mL-¹). Both devices deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Morphine Consumption', 'timeFrame': 'From end of surgery (Hour 0) to 48 hours post-operation (Day 2).', 'description': 'Total amount of intravenous morphine (in milligrams) administered via the Patient-Controlled Analgesia (PCA) device. This includes both the demand doses and any clinician-administered boluses.'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain Intensity', 'timeFrame': 'At 6, 12, 18, 24, 30, 36, 42, and 48 hours post-operatively.', 'description': 'Patient-reported pain intensity measured using a Visual Analogue Scale (VAS). The scale ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.'}, {'measure': 'Incidence of Opioid-Related Adverse Events (ORAEs)', 'timeFrame': 'From the end of surgery through 48 hours post-operatively.', 'description': 'The number of participants experiencing one or more of the following opioid-related adverse events: nausea, vomiting, pruritus (itching), excessive sedation (defined by a Richmond Agitation-Sedation Scale (RASS) score of -1 and below), or respiratory depression (respiratory rate \\< 8 breaths per minute).'}, {'measure': 'Duration of Hospital Stay', 'timeFrame': 'From date of surgery until hospital discharge (approximately 3-7 days).', 'description': 'The total number of days from the date of surgery (Day 0) to the date of hospital discharge.'}, {'measure': 'Time to First Post-operative Flatus', 'timeFrame': 'Up to 48 hours post-operatively.', 'description': 'The time interval (in hours) from the end of surgery until the patient first reports the passage of gas (flatus). This serves as a proxy for the resolution of post-operative ileus.'}, {'measure': 'Time to First Ambulation', 'timeFrame': 'Up to 48 hours post-operatively.', 'description': 'The time interval (in hours) from the end of surgery until the patient first takes steps outside of their bed with or without assistance.'}, {'measure': 'Patient Satisfaction With Pain Management', 'timeFrame': 'At the time of hospital discharge (approximately Day 3 to Day 7 post-operatively).', 'description': 'Patient-reported satisfaction with their pain management experience using a 5-point Likert scale. The scale consists of:\n\n1. = Very Dissatisfied\n2. = Dissatisfied\n3. = Neutral\n4. = Satisfied\n5. = Very Satisfied Total scores range from 1 to 5, where higher scores indicate greater satisfaction with the pain management protocol.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent', 'Analgesia', 'Ketamine', 'Morphine', 'Pain management', 'Pain-controlled', 'Spinal fusion'], 'conditions': ['Adolescent Idiopathic Scoliosis (AIS)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zin CS, Nazar NI, Rahman NSA, et al. Patterns of initial opioid prescription and its association with short-term and long-term use among opioid-naïve patients in Malaysia: a retrospective cohort study. BMJ Open. 2019;9:e027203. doi:10.1136/bmjopen-2018-027203'}, {'type': 'BACKGROUND', 'citation': 'Sveticic G, Gentilini A, Eichenberger U, Luginbühl M, Curatolo M. Combinations of morphine with ketamine for patient-controlled analgesia: a randomized, double-blind, cross-over study. Anesthesiology. 2003;98(5):1195-1205. doi:10.1097/00000542-200305000-00014'}, {'type': 'BACKGROUND', 'citation': 'Sveticic G, Farid R, Lauretti GR, et al. A safety audit of patient-controlled analgesia with ketamine and morphine after major surgery. Acta Anaesthesiol Scand. 2005;49(6):870-875. doi:10.1111/j.1399-6576.2005.00736.x'}, {'type': 'BACKGROUND', 'citation': 'Hodgman-Korth E, Kenyon NJ. Stability of morphine-ketamine admixtures for patient-controlled analgesia. J Pain Palliat Care Pharmacother. 2009;23:272-6.'}, {'type': 'BACKGROUND', 'citation': 'Roy JJ, Fortier C, Drolet P, et al. Physical compatibility of ketamine and morphine mixtures in PCA reservoirs. Can J Hosp Pharm. 2000;53:16-21.'}, {'type': 'BACKGROUND', 'citation': 'Carstensen M, Møller AM. Adding ketamine to morphine for intravenous patient-controlled analgesia for acute postoperative pain: a qualitative review of randomised trials. Br J Anaesth. 2010;104:401-6.'}, {'type': 'BACKGROUND', 'citation': 'Minoshima T, Fukushima S, Yokoyama H, et al. Intra-operative ketamine infusion reduces morphine requirement after adolescent spinal fusion: a randomised trial. Paediatr Anaesth. 2017;27:1064-71.'}, {'type': 'BACKGROUND', 'citation': 'Tornøe AS, Pind AH, Laursen CCW, Andersen C, Maagaard M, Mathiesen O. Ketamine for postoperative pain treatment in spinal surgery: systematic review with meta-analysis and trial sequential analysis. Acta Anaesthesiol Scand. 2023;67(10):1306-21. doi:10.1111/aas.14307'}, {'type': 'BACKGROUND', 'citation': 'Pendi A, Field R, Farhan SD, Eichler M, Bederman SS. Perioperative ketamine for analgesia in spine surgery: a meta-analysis of randomized controlled trials. Spine. 2018;43(5):E299-E307.'}, {'type': 'BACKGROUND', 'citation': 'Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review. Pain. 1999;82:111-25.'}, {'type': 'BACKGROUND', 'citation': 'Hasan MS, Abdul Razak N, Yip HW, Lee ZY, Chan CYW, Kwan MK, et al. Association between intraoperative remifentanil use and postoperative hyperalgesia in adolescent idiopathic scoliosis surgery: a retrospective study. BMC Anesthesiol. 2023;23:177. doi:10.1186/s12871-023-02127-8'}, {'type': 'BACKGROUND', 'citation': "Flood P, Rathmell JP, Shafer SL. Stoelting's Pharmacology and Physiology in Anesthetic Practice. 5th ed. New York: Wolters Kluwer; 2015."}, {'type': 'BACKGROUND', 'citation': 'Himmelseher S, Duriex ME. Ketamine for perioperative pain management. Anesthesiology. 2005;102:211-20.'}, {'type': 'BACKGROUND', 'citation': 'Hasan MS, Selvanathan P, Lee ZY, Chiu CK, Chan CYW, Kwan MK, Yunus SN. Perioperative intravenous lidocaine as an analgesic adjunct in adolescent idiopathic scoliosis surgery. Spine (Phila Pa 1976). 2020;45(20):E1261-E1269. doi:10.1097/BRS.0000000000003611'}, {'type': 'BACKGROUND', 'citation': 'Fletcher D, Stamer UM, Pogatzki-Zahn E, et al. Pain management after surgery: a consensus statement from the ESA. Eur J Anaesthesiol. 2015;32:88-98.'}, {'type': 'BACKGROUND', 'citation': 'Kaye AD, Urman RD, Rappaport Y, et al. Multimodal analgesia as an essential part of enhanced recovery protocols in the ambulatory settings. J Anaesthesiol Clin Pharmacol. 2019;35(Suppl 1):S40-5.'}, {'type': 'BACKGROUND', 'citation': 'Kwan MK, Chiu CK, Chan TS, Chong KI, Mohamad SM, Hasan MS, Chan CYW. Trajectory of postoperative wound pain within the first 2 weeks following posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Spine (Phila Pa 1976). 2019;44(18):E1075-E1082.'}, {'type': 'BACKGROUND', 'citation': 'Chiu CK, Chong KI, Chan TS, et al. The anatomical locations of postoperative pain and their recovery trajectories following posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Med J Malaysia. 2020;75(1):12-7.'}, {'type': 'BACKGROUND', 'citation': 'Yrjälä T, Helenius I, Rissanen T, Ahonen M, Taittonen M, Helenius L. The extension of surgery predicts acute postoperative pain, while persistent postoperative pain is related to the spinal pathology in adolescents undergoing posterior spinal fusion. Children. 2022;9(11):1729. https://doi.org/10.3390/children9111729'}, {'type': 'BACKGROUND', 'citation': 'Seki H, Ideno S, Ishihara T, et al. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis. 2018;13:17.'}, {'type': 'BACKGROUND', 'citation': 'Deepak AS, Ong JY, Choon D, Lee K, Chiu CK, Chan C, Kwan K. The clinical effectiveness of a school screening programme for idiopathic scoliosis in Malaysia. Malays Orthop J. 2017;11(3):41-6. https://doi.org/10.5704/MOJ.1703.018'}, {'type': 'BACKGROUND', 'citation': 'Lee JY, Moon SH, Kim HJ, Park M, Suh BK, Nam J, Jung J, Lee HM. The prevalence of idiopathic scoliosis in eleven-year-old Korean adolescents: A 3-year epidemiological study. Yonsei Med J. 2014;55(3):773-8. https://doi.org/10.3349/ymj.2014.55.3.773'}, {'type': 'BACKGROUND', 'citation': 'Lee WS, Tay CG, Lum SH. Textbook of Paediatrics and Child Health. Kuala Lumpur: Universiti Malaya Press; 2020. p. 547-8.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether adding low-dose ketamine to PCA morphine reduces opioid requirements after posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Selected patients aged 10-18 years undergoing elective AIS surgery at University Malaya Medical Centre will be randomised to ketamine-morphine or morphine-only PCA. The primary outcome is cumulative morphine consumption at 48 hours, with secondary outcomes including pain scores, opioid-related adverse effects, time to ambulation, and patient satisfaction. This study aligns with national priorities for safe opioid stewardship and enhanced peri-operative care in Malaysia.', 'detailedDescription': 'Posterior spinal fusion (PSF) is the definitive surgical treatment for patients with scoliosis. However, the procedure involves extensive tissue dissection, resulting in significant postoperative pain. Although patient-controlled analgesia (PCA) with intravenous morphine remains the current standard, the large doses required are frequently associated with side effects such as nausea, vomiting, pruritus, and sedation \\[4-6\\]. These complications delay mobilisation, prolong hospital stay, increase healthcare costs, and may contribute to opioid tolerance, undermining effective pain control.\n\nEnhanced Recovery After Surgery (ERAS) protocols strongly promote multimodal analgesia, which combines opioid and non-opioid agents to achieve synergistic pain relief while minimising opioid exposure. This strategy has been shown to reduce side effects, improve recovery, shorten hospital stay, and lower the risk of opioid-related tolerance, hyperalgesia, and potential long-term dependence. Despite these advantages, evidence for the use of ketamine-morphine PCA in scoliosis surgery remains limited, and subanaesthetic ketamine-though effective intraoperatively as an opioid-sparing agent-remains underutilised in postoperative PCA regimens. Our previous study demonstrated that co-administration of subanaesthetic ketamine (0.5 mg/kg) at induction reduced postoperative pain sensitivity and hyperalgesia typically associated with high-dose remifentanil infusion, a strong opioid analgesic \\[13\\]. This finding underscores the potential role of ketamine as an opioid-sparing adjunct.\n\nBuilding on this, we propose a single-centre, double-blind, randomised controlled trial in 114 idiopathic scoliosis patients undergoing elective PSF at University Malaya Medical Centre. Participants will be randomised to receive PCA containing ketamine-morphine (1 mg/mL + 1 mg/mL) or morphine (1 mg/mL) alone, with identical syringes to ensure allocation concealment. The primary endpoint is cumulative morphine consumption at 48 hours, while secondary outcomes include pain scores, opioid-related side effects, time to ambulation, and patient satisfaction.\n\nThis study aims to provide the first Malaysian evidence on an opioid-sparing PCA regimen, addressing national ERAS priorities and contributing to global opioid stewardship.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Aged \\> 10 years old\n2. Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).\n3. American Society of Anaesthesiologists (ASA) physical status I-II.\n\nExclusion criteria:\n\n1. Known hypersensitivity to morphine, ketamine or formulation excipients.\n2. Hepatic dysfunction (ALT or AST \\> 2 × upper limit of normal).\n3. Renal impairment (eGFR ≤ 60 mL min-¹ 1·73 m-²).\n4. Uncontrolled asthma or severe restrictive lung disease.\n5. Cardiac disease or clinically significant arrhythmia.\n6. Epilepsy.\n7. Intellectual disability precluding PCA use.\n8. Chronic opioid therapy or pre-operative pain \\> 3 months.\n9. Concomitant monoamine-oxidase inhibitor or tricyclic antidepressant therapy.\n10. History of severe postoperative delirium.'}, 'identificationModule': {'nctId': 'NCT07452705', 'acronym': 'KetaMorph', 'briefTitle': 'Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Patient-Controlled Analgesia (PCA) With Ketamine-Morphine (PCA KetaMorph) vs PCA Morphine for Postoperative Analgesia in Idiopathic Scoliosis Surgery - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025817-15467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine-Morphine PCA (1:1 ratio)', 'description': 'This group receives a ketamine-morphine PCA solution (1 mg mL-¹ + 1 mg mL-¹). This device deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion. The patient will use PCA for at least 48 hours duration.', 'interventionNames': ['Combination Product: Ketamine-Morphine PCA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine only PCA', 'description': 'This group receives morphine alone PCA (1 mg mL-¹). This device deliver a 1 mL bolus, enforce a five-minute lock-out and cap delivery at 20 mL per four hours, with no background infusion. The patient will use PCA for at least 48 hours duration.', 'interventionNames': ['Drug: Morphine (Intravenous patient-controlled analgesia)']}], 'interventions': [{'name': 'Ketamine-Morphine PCA', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['K-M'], 'description': 'The patient in this group will receive PCA Morphine (1mg/mL) with addition of Ketamine (1mg/mL) in comparison with the other group.', 'armGroupLabels': ['Ketamine-Morphine PCA (1:1 ratio)']}, {'name': 'Morphine (Intravenous patient-controlled analgesia)', 'type': 'DRUG', 'otherNames': ['M'], 'description': 'This patient will receive PCA Morphine only (1mg/mL).', 'armGroupLabels': ['Morphine only PCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'contacts': [{'name': 'NIK SHERINA HAIDI BINTI HANAFI, MBBS', 'role': 'CONTACT', 'email': 'niksherina@um.edu.my', 'phone': '+6079492802'}], 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'MUHAMMAD FAEEZ BIN MOHD YUSOH, MBBS', 'role': 'CONTACT', 'email': 'faeez@ummc.edu.my', 'phone': '+6013-5233915'}], 'overallOfficials': [{'name': 'SITI NADZRAH BINTI YUNUS, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to ethical and confidentiality considerations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Medical Officer', 'investigatorFullName': 'MUHAMMAD FAEEZ BIN MOHD YUSOH', 'investigatorAffiliation': 'University of Malaya'}}}}