An interventional study of Ketamine-Morphine PCA and Morphine (Intravenous patient-controlled analgesia) in Adolescent Idiopathic Scoliosis (AIS), sponsored by University of Malaya. Not yet recruiting at 1 site in Malaysia. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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.
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.
Enhanced 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.
Building 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.
This study aims to provide the first Malaysian evidence on an opioid-sparing PCA regimen, addressing national ERAS priorities and contributing to global opioid stewardship.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's planned enrollment of 114 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.
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Exclusion criteria:
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.
Combination Product: Ketamine-Morphine 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.
Drug: Morphine (Intravenous patient-controlled analgesia)
The patient in this group will receive PCA Morphine (1mg/mL) with addition of Ketamine (1mg/mL) in comparison with the other group.
Also known as: K-M
This patient will receive PCA Morphine only (1mg/mL).
Also known as: M
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.
Time frame: From end of surgery (Hour 0) to 48 hours post-operation (Day 2).
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the time of hospital discharge (approximately Day 3 to Day 7 post-operatively).
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Plan to share: No — Individual participant data will not be shared due to ethical and confidentiality considerations.
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University of Malaya