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Clinical Trial NCT07452705 (KetaMorph) for Adolescent Idiopathic Scoliosis (AIS) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery. (KetaMorph) 114 Adolescent
Clinical Trial NCT07452705 (KetaMorph) is an interventional study for Adolescent Idiopathic Scoliosis (AIS) and is currently not yet recruiting. Enrollment is planned to begin on 2 February 2026 and continue until the study accrues 114 participants. Led by University of Malaya, this study is expected to complete by 30 January 2028. The latest data from ClinicalTrials.gov was last updated on 5 March 2026.
Brief Summary
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 consu...Show More
Detailed Description
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 ...Show More
Official Title
Patient-Controlled Analgesia (PCA) With Ketamine-Morphine (PCA KetaMorph) vs PCA Morphine for Postoperative Analgesia in Idiopathic Scoliosis Surgery - A Randomized Controlled Trial
Conditions
Adolescent Idiopathic Scoliosis (AIS)Publications
Scientific articles and research papers published about this clinical trial:- 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
- Sveticic G, Gentilini A, Eichenberger U, Luginbühl M, Curatolo M. Combinations of mo...
Other Study IDs
- KetaMorph
- 2025817-15467
NCT ID Number
Start Date (Actual)
2026-02-02
Last Update Posted
2026-03-05
Completion Date (Estimated)
2028-01-30
Enrollment (Estimated)
114
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Adolescent
Analgesia
Ketamine
Morphine
Pain management
Pain-controlled
Spinal fusion
Analgesia
Ketamine
Morphine
Pain management
Pain-controlled
Spinal fusion
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalKetamine-Morphine PCA (1:1 ratio) 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. | Ketamine-Morphine PCA The patient in this group will receive PCA Morphine (1mg/mL) with addition of Ketamine (1mg/mL) in comparison with the other group. |
Active ComparatorMorphine only PCA 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. | Morphine (Intravenous patient-controlled analgesia) This patient will receive PCA Morphine only (1mg/mL). |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cumulative Morphine Consumption | 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. | From end of surgery (Hour 0) to 48 hours post-operation (Day 2). |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Post-operative Pain Intensity | 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. | At 6, 12, 18, 24, 30, 36, 42, and 48 hours post-operatively. |
Incidence of Opioid-Related Adverse Events (ORAEs) | 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). | From the end of surgery through 48 hours post-operatively. |
Duration of Hospital Stay | The total number of days from the date of surgery (Day 0) to the date of hospital discharge. | From date of surgery until hospital discharge (approximately 3-7 days). |
Time to First Post-operative Flatus | 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. | Up to 48 hours post-operatively. |
Time to First Ambulation | The time interval (in hours) from the end of surgery until the patient first takes steps outside of their bed with or without assistance. | Up to 48 hours post-operatively. |
Patient Satisfaction With Pain Management | Patient-reported satisfaction with their pain management experience using a 5-point Likert scale. The scale consists of:
1. = Very Dissatisfied
2. = Dissatisfied
3. = Neutral
4. = Satisfied
5. = Very Satisfied Total scores range from 1 to 5, where higher scores indicate greater satisfaction with the pain management protocol. | At the time of hospital discharge (approximately Day 3 to Day 7 post-operatively). |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
10 Years
Eligible Sexes
All
- Aged > 10 years old
- Idiopathic scoliosis scheduled for single-stage posterior spinal fusion (PSF).
- American Society of Anaesthesiologists (ASA) physical status I-II.
- Known hypersensitivity to morphine, ketamine or formulation excipients.
- Hepatic dysfunction (ALT or AST > 2 × upper limit of normal).
- Renal impairment (eGFR ≤ 60 mL min-¹ 1·73 m-²).
- Uncontrolled asthma or severe restrictive lung disease.
- Cardiac disease or clinically significant arrhythmia.
- Epilepsy.
- Intellectual disability precluding PCA use.
- Chronic opioid therapy or pre-operative pain > 3 months.
- Concomitant monoamine-oxidase inhibitor or tricyclic antidepressant therapy.
- History of severe postoperative delirium.
University of MalayaStudy Responsible Party
MUHAMMAD FAEEZ BIN MOHD YUSOH, Principal Investigator, Postgraduate Medical Officer, University of Malaya
Study Central Contact
Contact: MUHAMMAD FAEEZ BIN MOHD YUSOH, MBBS, +6013-5233915, [email protected]
1 Study Locations in 1 Countries
Kuala Lumpur
University Malaya Medical Centre, Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
NIK SHERINA HAIDI BINTI HANAFI, MBBS, Contact, +6079492802, [email protected]